IN THE HIGH COURT OF DELHI AT NEW DELHI

W.P.(C) NO. -------------2007

PUBLIC INTEREST LITIGATION

IN THE MATTER OF:

HARINDER S. SIKKA                                                .......  PETITIONER

VS.

THE UNION OF INDIA AND OTHERS                ....... RESPONDENTS

                                                                INDEX

PLACE: NEW DELHI

DATED:                                                                                 

ALI NAQVI

ADVOCATE FOR THE PETITIONER

68, TODARMAL ROAD, BENGALI MARKET,

NEW DELHI-110 001

IN THE HIGH COURT OF DELHI AT NEW DELHI

CWP NO. __________ OF 2007

(PUBLIC INTEREST LITIGATION)

MEMO OF PARTIES

IN THE MATTER OF:

HARINDER SIKKA

D 913, 1^ST FLOOR,

NEW FRIENDS COLONY

NEW DELHI - 110065                               -- PETITIONER

VERSUS

1.                 THE UNION OF INDIA

THROUGH THE MINISTRY OF HEALTH

AND FAMILY WELFARE,

DEPARTMENT OF HEALTH

AND FAMILY WELFARE,

NIRMAN BHAVAN

MAULANA AZAD ROAD

NEW DELHI - 110011

2.                 CENTRAL DRUGS STANDARDS CONTROL

ORGANISATION (CDSCO)

THROUGH THE DRUGS CONTROLLER GENERAL (INDIA)

NIRMAN BHAVAN

MAULANA AZAD ROAD

NEW DELHI - 110011                             --RESPONDENTS

PLACE: NEW DELHI

DATED:                                                               

ALI NAQVI

ADVOCATE FOR THE PETITIONER

68, TODARMAL ROAD, BENGALI MARKET,

NEW DELHI-110 001

SYNOPSIS

The widespread manufacture and sale of spurious drugs in India places every member of the general public at serious risk to their life.  According to several reports, out of the approximately Rs. 19,000 crores worth of business annually in the pharmaceutical sector in India, approximately Rs. 4,000 crores is on account of spurious drugs alone. Considering the huge market for spurious drugs and the failure of the Government to take adequate steps to counter the threat, all of us are, on a day to day basis, exposed to the very dangerous possibility of consuming fatal sub-standard drugs. The menace of spurious drugs violates the fundamental right to life guaranteed under Article 21 of the Constitution.  The extreme danger posed by spurious drugs can be illustrated by a few commonplace examples.  Among the spurious drugs commonly found in the market in India are fake insulin which may be taken by an unsuspecting diabetic, fake chemotherapy that may be administered to a final-stage cancer patient, the use of chalk instead of paracetamol in painkillers, or the use of tap-water presented as adrenaline, which may be used in an attempt to revive a patient who has suffered cardiac arrest, without any effect until it is too late.  Other spurious drugs contain the active ingredient in a lower potency level, while the end consumer may pay for normal potency, resulting in substantial profit margin for the manufacturer and seller.  Sub-strength spurious drugs such as anti-malarial drugs not only fail to cure but over time, create resistance in the malarial parasite with disastrous consequences for the patient.  Yet other spurious drugs are contaminated, containing substances injurious to health, such as contaminated intravenous drips and eye drops that are supposed to cure but instead cause blindness.  Patients of diabetes and other ailments who require drugs on an almost daily basis are at an even higher risk.

The menace of spurious drugs is largely unchecked because of major inadequacies and lacunae in the existing regulatory scheme. These lacunae were recognized by this Hon’ble Court in its judgement and order date 30.7.2003 in People’s Union for Civil Liberties vs. Union of India & Ors. 105 (2003) DELHI LAW TIMES 937 (DB) wherein it observed at para 54

”Unfortunately a very big market of spurious drugs is flourishing in our country. Guilty people who play with the lives of millions are rarely brought to books. It is unfortunate that no action is taken against them. There is hardly any deterrence against such enemies of humanity. While taking into consideration all the facts and circumstances we deem it appropriate to issue some directions. We recommend to Union of India that a suitable legislation be enacted so that severe punishment be given to people who are involved in the manufacture, distribution, trade and business of spurious drugs.”

The penalties and provisions existing under the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the “Act”) are ineffective. One of the reasons for the existing penalties not being effective is that the manufacture and sale of spurious drugs is primarily a clandestine activity which is showing increasing involvement of organized crime in recent years. Besides, offenders are able to easily obtain bail as the offences are non-cognizable and bailable under the existing provisions of the Act. The offenders remain on bail due to delay in disposal of cases for manufacture and sale of adulterated and spurious drugs. 

The Central Government constituted an Expert Committee under the chairmanship of Dr. R.A. Mashelkar, Director General of Council of Scientific and Industrial Research in January, 2003 to undertake a comprehensive examination of drug regulatory issues, including the problem of spurious drugs and to evaluate the extent of the problem of spurious drugs and recommend measures required to deal with the problem effectively. The Committee, in its report of November 2003, inter alia, recommended that penalties be enhanced, a Special Court be designated for the speedy trial of spurious drugs cases, offences relating to spurious drugs be made cognizable and non-bailable and the police be authorized to initiate prosecution for offences related to spurious drugs. However, more than three years after the date of the said Report, none of its recommendations have been implemented by the Respondents. This state of affairs constitutes a violation of the fundamental right to life guaranteed under Article 21 of the Constitution.

By way of the present petition in public interest, the Petitioner is, inter alia, seeking to enforce the fundamental right under Article 21 by way of issuance of directions to the Respondents to fill the lacunae in the regulatory scheme in respect of spurious drugs by implementing various recommendations of the Mashelkar Committee Report dated November 2003, more clearly detailed hereinafter, to secure a more effective, stringent and efficacious regulatory scheme to tackle the growing menace of spurious drugs in the country.

The Petitioner is also seeking the framing of guidelines setting stringent quality control standards in the prevailing governmental drug procurement policy and practice which is vital to save lives endangered by the spread of spurious drugs.  The government, under its current drugs procurement policy, buys life saving drugs on the basis of lowest quotations (L I) and not necessarily high qualitative standards, as a result of which scores of government - run dispensaries and hospitals are flooded with spurious or sub-standard drugs. The rates quoted by these so-called pharma companies are sometimes much lower than even the basic costs of raw materials. Many established pharmaceutical companies have even stopped bidding for government procurement orders for this reason, which allows a free hand to manufacturers of spurious drugs to pump large volumes of such drugs into the market, with tragic consequences for the general public.

LIST OF DATES

1940                              The Drugs Act was enacted.

1962                              The word “cosmetics” was inserted by Act 21 of 1962,  S. 2 (w.e.f. 31.5.1972) and the legislation came to be know as the Drugs and Cosmetics Act, 1940

January, 2003            The Central Government constituted an Expert Committee under the chairmanship of Dr. R. A. Mashelkar, Director General of the Council of Scientific and Industrial Research in January, 2003 to undertake a comprehensive examination of drugs regulatory issues, including the problem of spurious drugs, evaluate the extent of the problem of spurious drugs and recommend measures required to deal with the problem effectively.

July 30, 2003              A Division Bench of this Hon’ble Court delivered a judgement in People’s Union for Civil Liberties v. Union of India & Ors. 105 (2003) DELHI LAW TIMES 937 (DB) wherein this Hon’ble Court was pleased to observe that:

                                  “Unfortunately a very big market of spurious drugs is flourishing in our country. Guilty people who play with the lives of millions are rarely brought to books. It is unfortunate that no action is taken against them. There is hardly any deterrence against such enemies of humanity. While taking into consideration all the facts and circumstances we deem it appropriate to issue some directions. We recommend to Union of India that a suitable legislation be enacted so that severe punishment be given to people who are involved in the manufacture, distribution, trade and business of spurious drugs. The Ministry of Health and the Director General of Health Services and other concerned agencies without further loss of time must ensure that the drug manufacturers should not be permitted to market their drugs unless the quality of the drug is approved by a high level committee or body consisting of doctors and other experts of impeccable integrity and eminence. We recommend the Government of India to constitute a committee within a period of three months to see that no new drug be permitted to be launched in the market without the approval of this High Panel Committee.”

August, 2003              The Mashelkar Committee submitted its interim report.

November, 2003          The Committee submitted its final report, recommending several measures to tackle the menace of spurious drugs, inter alia:

(i)                increasing the severity of the penalties for offences related to manufacturing and selling of spurious drugs, including making them cognizable and non-bailable offences;

(ii)              empowering the Central and State Governments to set up special courts for the prosecution of offences under the Drugs and Cosmetics Act including those related to spurious drugs; and

(iii)            enabling the police to initiate prosecutions against offenders in relation to spurious drugs whereas only Drugs Inspectors are permitted to do so under the Drugs and Cosmetics Act.

December, 2003         A bill to implement the recommendations of the Mashelkar Committee Report, The Drugs and Cosmetics (Amendment) Bill, 2003, was introduced in the Lok Sabha. However, the said bill lapsed on the dissolution of the XIII Lok Sabha.

May 11, 2005              Another bill to implement the recommendations of the Mashelkar Committee Report, The Drugs and Cosmetics (Amendment Bill) 2005, was introduced in the Rajya Sabha and was referred to the parliamentary standing committee on Health and Family Welfare.

December 21, 2005   The Committee submitted its report to both the houses of Parliament, but no further action has been taken since.

August 29, 2006          The Petitioner was felicitated by the Global Anti- Counterfeiting Group for outstanding service in the field of anti-counterfeiting in India, at a function presided over                                     by the Hon’ble Mr. Justice K.G. Balakrishnan, Hon’ble Chief Justice of India.

Till date                       The recommendations of the Mashelkar Committee Report have not been implemented and the trade in spurious drugs continues unabated.

IN THE HIGH COURT OF DELHI AT NEW DELHI

CWP NO. __________ OF 2007

(PUBLIC INTEREST LITIGATION)

IN THE MATTER OF:

HARINDER SIKKA

D 913, 1^ST FLOOR,

NEW FRIENDS COLONY

NEW DELHI - 110065                         -- PETITIONER

VERSUS

1.     THE UNION OF INDIA

THROUGH THE MINISTRY OF HEALTH

AND FAMILY WELFARE,

DEPARTMENT OF HEALTH

AND FAMILY WELFARE,

NIRMAN BHAVAN

MAULANA AZAD ROAD

NEW DELHI – 110011

     2.  CENTRAL DRUGS STANDARDS CONTROL

ORGANISATION (CDSCO)

THROUGH THE DRUGS CONTROLLER GENERAL (INDIA)

NIRMAN BHAVAN

MAULANA AZAD ROAD

NEW DELHI - 110011                         --RESPONDENTS

CIVIL WRIT PETITION UNDER ARTICLE 226 OF THE CONSTITUTION OF INDIA IN PUBLIC INTEREST SEEKING A WRIT OF MANDAMUS DIRECTING THE UNION OF INDIA TO IMPLEMENT THE RECOMMENDATIONS OF THE MASHELKAR COMMITTEE IN ITS REPORT DATED NOVEMBER 2003, TO ENABLE EFFECTIVE, SWIFT AND SEVERE ACTION AGAINST INDIVIDUALS UNDERTAKING MANUFACTURE, DISTRIBUTION AND SALE OF SPURIOUS DRUGS

AND

FOR GRANT OF OTHER RELIEFS AS PRAYED FOR HEREUNDER

AND

FOR THE ISSUANCE OF SUCH APPROPRIATE WRIT, ORDER OR DIRECTION WHICH THIS HON’BLE COURT DEEMS JUST AND FIT IN THE FACTS AND CIRCUMSTANCES OF THE CASE.

To,

The Hon’ble Chief Justice and his Companion Justices

of the High Court of Delhi

MOST RESPECTFULLY SHEWETH:

1.                 That there is widespread manufacture and sale of spurious drugs in the country, which places every member of the general public at serious risk to their life.  The annual turnover for trade in spurious drugs in India has been estimated at Rs. 4000 crores. The menace of spurious drugs is unchecked largely because there exist major lacunae in the current regulatory scheme.  The penalties and provisions existing under the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the “Act”) are ineffective. One of the reasons for the existing penalties not being effective is that the manufacture and sale of adulterated and spurious drugs is primarily a clandestine activity which is showing an increased involvement of organized crime in recent years. Besides, offenders are able to easily obtain bail as the offences are non-cognizable and bailable under the existing provisions of the Act. The offenders remain on bail due to a delay in disposal of cases for the manufacture and sale of adulterated and spurious drugs.  The Central Government constituted an Expert Committee under the chairmanship of Dr. R.A. Mashelkar, Director General of the Council of Scientific and Industrial Research in January, 2003, to undertake a comprehensive examination of drug regulatory issues, including the problem of spurious drugs, evaluate the extent of the problem of spurious or sub-standard drugs and recommend measures required to deal with the problem effectively. The Committee, in its report of November 2003, inter alia, recommended that penalties be enhanced, a Special Court be designated for speedy trial of spurious drugs cases, offences relating to spurious drugs be made cognizable and non-bailable and the police be authorized to initiate prosecution for offences related to spurious drugs.  However, more than three years after the date of the said Report, none of its recommendations has been implemented by the Respondents. This state of affairs constitutes a violation of the fundamental right to life guaranteed under Article 21 of the Constitution.  By way of the present petition, the Petitioner is, inter alia, seeking to enforce the fundamental right under Article 21 by way of issuance of directions to the Respondents to implement various recommendations of the Mashelkar Committee Report dated November 2003, more clearly detailed hereinafter, to fill the lacunae in the regulatory scheme to tackle the growing menace of spurious drugs in the country.

2.                 The Petitioner is also seeking the framing of guidelines setting stringent quality control standards in the prevailing governmental drug procurement policy and practice which is vital to save lives endangered by the spread of spurious drugs. The government, under its current drugs procurement policy, buys life saving drugs on the basis of lowest quotations (L I) and not necessarily high qualitative standards, as a result of which scores of government- run dispensaries and hospitals are flooded with spurious or sub-standard drugs. The rates quoted by these so-called pharmaceutical companies are sometimes much lower than even the basic cost of raw materials. Many established pharmaceutical companies have even stopped bidding for government procurement orders for this reason, which allows a free hand to manufacturers of spurious drugs to pump large volumes of such drugs into the market, with tragic consequences for the general public.

FACTS OF THE CASE:

Introduction to the Petitioner:

3.                 That the Petitioner herein, a citizen of India, is a Director/Senior President, Corporate of a reputed pharmaceutical company and is an ardent crusader in the battle against the manufacture and sale of spurious drugs in India and abroad. In this connection, the Petitioner has been felicitated with many national and international   awards for his relentless work in trying to protect thesuha people from the menace of spurious drugs. That the Petitioner was on 29.08.2006 felicitated by the Global Anti-Counterfeiting Group for outstanding service in the field of anti-counterfeiting in India, at a function presided over by the Hon’ble Mr. Justice K.G. Balakrishnan, Hon’ble Chief Justice of India. That the Petitioner has over the years actively used various fora and media to create awareness of the menace of spurious drugs amongst the public at large. Copies of articles by the Petitioner on the subject published in leading newspapers and journals over the last several years are collectively marked and annexed herewith as ANNEXURE  - A hereto.

Introduction to the Respondents:

4.                 The Respondent No. 1 is the Union of India and the Petition is being filed, inter alia, against the Ministry of Health and Family Welfare, as the actions impugned herein are the acts of omission and inaction on the part of the said Ministry of the Government of India.

5.                 The Respondent No. 2 is the Central Drugs Standards Control Organization (CDSCO) headed by the Drugs Controller General (India), which is a statutory authority performing various statutory functions of the Central Government under the Drugs and Cosmetics Act, 1940.

Case in Detail

6.                 It is submitted that the use of the phrase “spurious drug” in the present petition encompasses many categories of drugs, all of which are extremely dangerous.  The use of the phrase “spurious drug” herein includes both (i) drugs that are “adulterated” under Section 17A of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the “Act”), which includes inter alia cases where any substance has been mixed with the drug so as to reduce its quality or strength, and (ii) drugs that are “spurious” under Section 17B of the Act, which includes inter alia a drug that is manufactured under a name which belongs to another drug, or a drug that is an imitation of, or a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug, if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist, or if it has been substituted wholly or in part by another drug or substance, or if it purports to be the product of a manufacturer of whom it is not truly a product. 

7.                 That the manufacture and sale of spurious drugs is a very attractive business because the use of fake or sub-strength ingredients, or the passing off of a drug as one manufactured by a major brand, results in very low production costs and therefore substantial profit margins.

8.                 That the menace of spurious drugs has wreaked havoc in the lives of hundreds of thousands of innocent people in the country. However, the Respondents have, by their inaction failed to secure the fundamental right to life of the people in this country which is guaranteed under Article 21 of the Constitution.  It is submitted that this Hon’ble Court has time and again, in exercise of its jurisdiction under Article 226 of the Constitution, intervened to enforce the fundamental rights conferred under Part III of the Constitution, of which the right to life enshrined in Article 21 is one of the most important.

9.                 That in this context it is important and relevant to refer to a judgment of the Division Bench of this Hon’ble High Court presided over by Hon’ble Justice Dalveer Bhandari, in a public interest litigation writ petition filed by the People’s Union for Civil Liberties, reported as People’s Union for Civil Liberties v. Union of India & Ors. 105 (2003) DELHI LAW TIMES 937 (DB):

54. We are deeply disturbed by the purchase of contaminated and spurious IV fluids in the hospitals. This indeed is a very alarming and serious problem faced by this country. Unfortunately a very big market of spurious drugs is flourishing in our country. Guilty people who play with the lives of millions are rarely brought to books. It is unfortunate that no action is taken against them. There is hardly any deterrence against such enemies of humanity. While taking into consideration all the facts and circumstances we deem it appropriate to issue some directions. We recommend to Union of India that a suitable legislation be enacted so that severe punishment be given to people who are involved in the manufacture, distribution, trade and business of spurious drugs. The Ministry of Health and the Director General of Health Services and other concerned agencies without further loss of time must ensure that the drug manufacturers should not be permitted to market their drugs unless the quality of the drug is approved by a high level committee or body consisting of doctors and other experts of impeccable integrity and eminence. We recommend the Government of India to constitute a committee within a period of three months to see that no new drug be permitted to be launched in the market without the approval of this High Panel Committee.

55.It is also imperative that once a drug has been permitted to be marketed, the quality of the same be periodically evaluated preferably after every six months. The Police Commissioner or other concerned agencies be directed to conduct periodical raids on the manufacturers and dealers of these spurious drugs. To ensure that contaminated IV fluids are not purchased at a cost of Rs. 23 to 29 per bottle as opposed to the then prevailing price of Rs. 10 to 12 per bottle in future we deem it appropriate to direct that every Government hospital must have a hospital evaluation committee for the purchase of equipments, maintenance etc.

56. The Ministry of Health and Family Welfare must ensure that the drugs which have been banned in other parts of the world may not be permitted to be sold in this country.

A copy of the said judgment is marked and annexed herewith as ANNEXURE - B hereto.

10.             That despite the fact that this Hon’ble Court has taken judicial notice of the endemic problem of spurious drugs in the country, passing strictures against the failure of law enforcement agencies to deter the perpetrators and recommending severe punishment for people responsible for manufacturing and selling spurious drugs, the offences relating to manufacture and sale of spurious drugs under the Indian Penal Code and the Act are and continue to be, for the most part, bailable and non-cognizable.  A chart of the offences under the Indian Penal Code and the Act relating to manufacture and sale of spurious drugs is made ANNEXURE C hereto.

11.             That considering the huge market for spurious drugs and the failure of the Respondents to take adequate steps to counter the threat, all of us are on a day to day basis exposed to the very dangerous possibility of consuming fatal sub-standard drugs. The extreme danger posed by spurious drugs can be illustrated by a few commonplace examples. Among the spurious drugs commonly found in the market in India are fake insulin which may be taken by an unsuspecting diabetic, fake chemotherapy that may be administered to a final-stage cancer patient, the use of chalk instead of paracetamol in painkillers, or the use of tap-water presented as adrenaline, which may be used in an attempt to revive a patient who has suffered cardiac arrest, without any effect until it is too late.  Other spurious drugs contain the appropriate ingredient in a lower potency level, while the end consumer may pay for normal potency, resulting in a substantial profit margin for the manufacturer and the seller.  Sub-strength spurious drugs such as anti-malarial drugs not only fail to cure but over time, create resistance in the malarial parasite with disastrous consequences for the patient.  Yet other spurious drugs are contaminated, containing substances injurious to health, such as contaminated intravenous drips and eye drops that are supposed to cure but instead cause blindness.  Patients of diabetes and other ailments who require drugs on almost a daily basis are at an even higher risk.

12.             That the consumption of spurious drugs, sub-strength drugs and drugs without any medicinal properties at all, slow down or retard treatment thereby causing grave long term consequences.  In many cases, spurious drugs act as slow and stealthy killers without doing any immediate damage, in the following way. A spurious drug may contain the active ingredient in a strength not sufficient to treat the disease but which is of a strength sufficient to build up immunity and therefore resistance to the active ingredient in the organism that causes the ailment. The patient who regularly takes such a drug believes he or she is being treated, little knowing that instead of treating the ailment the spurious drug is increasing the resistance of the organism that is causing the ailment.  The patient has thereby lost precious time and the ailment may deteriorate beyond a level that can be cured and by the time a full-strength drug is used, it may be useless in the case of that particular patient. Such cases, although difficult to prove, occur with great frequency. Thus, a below-strength drug or a zero strength drug which may other wise be harmless in terms of its ingredients, is as harmful and dangerous as a drug with harmful or noxious ingredients. 

13.             That as per a special report by Aaj Tak television news channel broadcast on 21.7.2003, the spurious drugs market is thriving on common over-the-counter drugs as well as life-saving drugs. It is understood that common drugs like pain killers, antibiotics, anti-hormonal, anti–malaria, anti–diabetes, and anti-hypersensitivity drugs and steroids, are commonly manufactured and sold using ingredients like chalk, thereby substantially diluting the potency of the medicine. The report suggests continuing illegal business in spurious drugs in Kanpur, Patna, Delhi and Gujarat. This would mean that effective treatment of common cold, malaria, viral fever, diabetes, tuberculosis and such like is in all likelihood being compromised without our knowledge.

14.             The CNBC news channel in its news report dated 12.06.2003 showed a specific instance where a patient suffering from Wilson’s disease was sold spurious medicine against a proper receipt. Moreover as per the report, five out of the six laboratories to whom the samples were sent for tests refused to test the medicines, in complete disregard of the provisions of the Act.

15.             According to a Zee Business news channel report, Bhagirath Palace in Chandni Chowk, New Delhi witnesses business in spurious/fake/adulterated drugs to the tune of Rs. 200 crores annually. According to the said report, out of the Rs. 19,000 crores worth of business in the pharmaceutical sector in India approximately Rs. 4,000 crores is on account of spurious/fake/adulterated drugs alone.

16.             That in a news documentary aired by the British Broadcasting Corporation (BBC) news channel on 11.09.2005, organised Indian drug syndicates along with their machinery and factories have been captured on video, demonstrating how they produce sub-standard and/or spurious drugs rampantly and without any fear of the system. That a copy of the VCD or DVD carrying the abovementioned news reports is marked and annexed herewith as ANNEXURE D hereto. A copy of only the relevant excerpts from the said DVD/VCD has been compiled in another VCD, fourteen minutes in duration, and is made Annexure D1 hereto.

17.             That in its judgement in People’s Union for Civil Liberties v. Union of India & Ors.  reported at 105 (2003) DELHI LAW TIMES 937 (DB), this Hon’ble Court was pleased to notice that Delhi’s Bhagirath Palace in Chandni Chowk is one the three main centres of the Rs. 4,000 crores annual trade in spurious drugs in India:

“57.It may be pertinent to mention that a prominent national newspaper "The Indian Express" on 27th July, 2003 published an article titled "Certified den of fake drugs"which also throws light on this serious problem. The relevant portion of the Article reads as under:-

" Bhagirath Palace in the Walled City runs a clandestine empire in spurious drugs and its notoriety is now part of official records. The Confederation of Indian Industries (CII) has identified the area as a principal distribution and probably the main production centre for spurious medicines in northern India. Lakhs of rupees exchange hands here on a daily basis - at times promising 10 or even 1000 times more profit per cent for retailers."

58. It is also stated in the article that "the three-storied junction park building and the Central Bank building are the hub of these activities. The heaps of medicines and porters loading huge cartons, suggest how business goes even on the rundown and dangerous staircase. The owners are busy taking orders over their mobile phones while their staff tries to squeeze in as much medicine as possible in a single box. These distribution centers function from small cubicles and have five to six salesmen jostling for space."

59.It is also stated in the article that the Confederation of Indian Industries has identified Bhagirath Palace in Delhi as one of the three main centers of the Rs.4,000-crore spurious drug trade in India.”

18.             That with cheap and improved packaging methods, it has become very easy to counterfeit drugs such that even manufacturers, let alone members of the public, cannot recognize the difference, thereby increasing the risk manifold for the people at large.

19.             The Drugs and Cosmetics Act, 1940 is the primary legislation dealing with the import, manufacture, distribution and sale of drugs and cosmetics in the country. The Act sets forth, inter alia, a scheme which purports to regulate the manufacture and sale of spurious drugs.  Unfortunately, the said scheme suffers from major inadequacies and lacunae, as a result of which the said Act, in its present form, has been unable to check the spread of spurious drugs. It is submitted that the failure of the prevailing legislative scheme to rein in the menace of spurious drugs violates the fundamental right to a healthy life of all sections of society without exception.

20.             That it is difficult to imagine that the vast spurious drug industry is thriving without the knowledge of the drug inspectors who are the mainstay of the scheme for enforcement of drug standards under the Act. Surprisingly, the Act is silent on possible deviant drug inspectors, although they are as much responsible for causing the deaths of innocent patients as are manufacturers and sellers of spurious drugs. 

21.             That the glaring and unpardonable failure of the State machinery in dealing with the alarming rise of the spurious drug industry and thereby putting the lives of millions at risk is clearly highlighted in the a report published in the Business Standard daily newspaper on December 28, 2005:

“Pyrazinamide tablets, meant to control tuberculosis from spreading, were found to be substandard in 2001 by various government laboratories.

The health ministry, however, instead of blacklisting the company, merely de-registered the drug despite being aware of the fact that such an action would have no effect on the ground. There is no foolproof system of recall of drugs in India.

Therefore, once a medicine is released into the market, the distribution network is so widespread that it becomes nearly impossible to recall the defective drug.

Ironically, the same company was caught again in 2003 for supplying sub-standard anti-TB drugs.

The company survived yet again and continues to do so till date, thanks to the inadequate laws and unwilling government machinery even as the spurious drug was consumed by gullible patients despite the official recall.”

22.             That efforts by the Indian Pharmaceutical Alliance, an independent task force, have resulted in the arrest of 51 people in two years and the seizure of Rs. 12 crores worth of spurious drugs as per a news report dated 05.08.2003 in The Telegraph. This news report also goes on to suggest that the spurious and fake drug market in India may be worth more than Rs. 4,000 crores. A bare perusal of the report suggests that the prevailing legislative scheme does not have sufficient teeth to deal with the issue of spurious drugs. A copy of the report dated 05.08.2003 along with another relevant news report  check whether any others are relevant are marked and annexed collectively herewith as ANNEXURE E (Colly).

23.             That the pharmaceutical companies also seem to be suffering from a culture of denial and secrecy about the epic proportions of the problem, in the absence of effective mechanism and lack of governmental support.

24.             That as per various newspaper reports, many Latin American and African countries have lodged complaints against India for exporting spurious drugs. That the United States has put India on the Special 301 watch list. A Copy of the relevant newspaper report dated 15.08.2003 in the INDUS TIMES is marked and annexed herewith as ANNEXURE F hereto.

25.             That the Petitioner, therefore, welcomed the constitution of the Mashelkar Committee, an expert committee set up in January 2003, by the Ministry of Health and Family Welfare, Government of India under the Chairmanship of Dr. R. A. Mashelkar, DG, CSIR and Secretary to Government of India. Other committee members included eminent scientists, lawyers, representatives of some States and Industry and Consumer Associations. The committee submitted its interim report in August, 2003 and its final report in November, 2003. The said report has, inter alia, brought out the abject failure of the Drugs and Cosmetics Act, 1940, in its present form, especially with regard to its penal provisions. The Committee has also noted with dismay that most of the prosecution cases pertaining to offences related to spurious drugs remain undecided for years. Relevant excerpts of the executive summary from the said Report are reproduced herein below:

“17.    The Committee noted with dismay that most of the prosecution cases pertaining to offences related to spurious drugs remain undecided for years. There is no greater deterrent than a ‘severe’, ‘sure’ and ‘swift’ punishment. This problem needs to be solved squarely by making a separate provision for speedy trials of such offences.

18.     For effective and successful implementation of the penal steps, it is necessary to involve the Police authorities in addition to the Drugs inspectorates, at an early stage, by authorising them to file prosecution for spurious drug offences under the Drugs & Cosmetics Act. It may be necessary to invoke changes in the related statutory provisions including fresh legislation for effective implantation of the steps needed to be taken for both punitive and deterrent punishment to those involved in criminal acts of manufacture and distribution of drugs, which may lead to mortality or serious threat to life of innocent consumers.

19. The Committee recommends that Drugs and Cosmetics Act should be suitably amended and the maximum penalty for sale and manufacture of spurious drugs causing grievous hurt or death should be enhanced from life imprisonment to death. Likewise, the Government should make the penalties more deterrent for other related offences.

20.             While the prevailing penalties are decided by the courts following normal legal procedures, it is imperative that there should be an effective deterrence against such offenders at the investigation level itself. The Committee, therefore, recommends a specific provision in the Drugs and Cosmetics Act that will allow persons indulging in spurious drug offences to be detained for a minimum period.”

Relevant excerpts from the detailed findings of the Report are as follows:

“10.2  By amendment of The Drugs and Cosmetics Act in 1982, the punishments for various offences were rationalized and life imprisonment was included as penalty for sale and manufacture of a spurious drug that causes grievous hurt or death. It was, however, noted that so far not a single prosecution has resulted in life imprisonment. While some members of the Committee suggested that for real fear among the possible offenders the penalty should now be enhanced from life imprisonment to death, some others were of the view that legal proceeding in cases involving death penalty may result in very complicated and lengthy trials. It was also agreed that even in cases of spurious drugs that are not likely to cause grievous hurt or death, the penalty should be enhanced with increased fine. The Committee recommends that the existing provisions under Section 27 of Drugs & Cosmetics Act need to be amended.

10.3   It was the general view of the Committee that these offences should be made cognizable and non-bailable. At present, the offenders usually get bails and the prosecutions normally take about 10 to 15 years for decision. In many cases, the offender may get away with minor punishment whereas in all likelihood, he continues to indulge in spurious drug trade/manufacture during the period of trial. It is considered necessary that offences related to spurious drugs are made non-bailable.

10.4        The Committee noted that in Gujarat State, legislation called Prevention of Anti Social Activities Act. (PASA), which allows detection of suspected offenders, is being used in spurious drug offences. In Uttar Pradesh, provisions of National Security Act (NSA) to book habitual spurious drug offenders are reported to be used.

10.5        The Committee also examined the provisions of Narcotic Drugs and Psychotropic Substances Act where the offences are non-bailable and provide for detention of the accused. It was felt that similar provision should be included in the Drugs and Cosmetics Act so that the courts may consider applications for bail only after a period of 3 months.

10.6        The existing provisions, 274, 275 & 276 of I.P.C./Cr. P.C. related to drug offences are bailable and cognizable and are not in consonance with the provisions of Drugs and Cosmetics Act. There is no mention of spurious drug offence in the Cr.P.C. Therefore, in order to ensure a uniform legislative intent reflecting upon the gravity of offences, it is essential to delete the existing provision form the statute.

10.7         The Committee also noted that sale of spurious drugs takes place almost always without bills and hence the penalty for dealers who are unable to produce authentic documents in support of their purchases should be made more stringent so that they exercise more diligence while procuring their drug supplies from unauthorized sources. The Committee felt that it was better to have a strong deterrence by making penalties more severe.

10.8         The Committee noted that currently the legal proceedings are far too complicated and lengthy; the process moves slowly and the conviction rate is low. At least in the core of spurious drug offences, quick disposal and immediate/appropriate punishment is called for, as it would act as a true deterrent. The Committee, therefore, recommends that a provision should be made under Drugs and Cosmetics Act to empower State and Central Government to constitute special courts for trial of offences under this Act.

10.9        The Committee felt that since the entire process of filing of prosecution to completion of trials is a lengthy process, it becomes an exercise in futility to prosecute licensees for minor offences. For example, for offences Under Drugs Price Control Order (DPCO), even if there is an over charge of ten paise, the only remedy provided is prosecution which is considered to be infructuous by the Drug Authorities. For this purpose it was suggested that a provision for compounding of offences may be included in Drugs and Cosmetics Act for commission of minor offences.

10.10    The Committee noted the functions of the officers of regulatory system are mostly of technical nature, whereas manufacture and sale of spurious drugs is a criminal activity that requires specialized training and skills as well as help of police. The Committee observed that under the present provisions of Drugs and Cosmetics Act, only Drugs Inspector is authorized to file prosecutions. It was felt that whenever a spurious drug case is detected and investigated by police, they should also have the power to prosecute independently. The Drugs and Cosmetics Act, therefore, needs to be amended to authorize the police also to file prosecutions.

10.11A detailed proposal for the amendment of various provisions pertaining to drug offences for the consideration of the Government is submitted by the Committee (Annexure 13).”

A copy of the report is annexed herewith as ANNEXURE G.

26.             That the Mashelkar Committee Report identifies several major inadequacies or lacunae in the current legislative scheme to deter and prevent the manufacture and sale of spurious drugs.  Firstly, penalties for offences related to the manufacture and the sale of spurious drugs are not severe enough.  In some cases, they are so lenient as to make a mockery of the tragic and widespread consequences of the trade in spurious drugs.  For instance, the maximum penalty for adulteration of drugs under Section 74 of the IPC is imprisonment for six months and a fine of Rs. 1000.  The offence is both non-cognizable and bailable. Under Section 27(b) of the Drugs and Cosmetics Act, a manufacturer or seller of an adulterated drug (as defined in Section 17A of the Act) faces a penalty of imprisonment of only up to three years and a fine of not less than just Rs. 5000.  This offence is also non-cognizable and bailable.  Such penalties cannot possibly act as a deterrent to persons who are attracted by the substantial profit margins offered by business in spurious drugs and therefore need to be made substantially more severe.

27.             Secondly, the Mashelkar Committee Report concludes that at present, persons engaged in the manufacture or the sale of spurious drugs usually get bail and the prosecutions normally take about 10 to 15 years for decision. In many cases, the offender may get away with minor punishment whereas in all likelihood, he continues to indulge in spurious drug trade or manufacture during the period of trial. Therefore, it is necessary that the Respondents implement the recommendation of the said Report that offences related to spurious drugs be made non-bailable and that provisions similar to those in the Narcotic Drugs and Psychotropic Substances Act should be included in the Drugs and Cosmetics Act so that the Courts may consider applications for bail only after a period of three months.

28.             Thirdly, the Mashelkar Committee Report concludes that the sale of spurious drugs takes place almost always without bills and hence the penalty for dealers who are unable to produce authentic documents in support of their purchases should be made more stringent so that they exercise more diligence while procuring their drug supplies from unauthorized sources. It is therefore necessary, in order to stem the trade in spurious drugs, to implement the recommendation of the Committee Report to make the penalty for such offences severe.

29.             Fourthly, the Mashelkar Committee notes that currently the legal proceedings in cases of spurious drugs-related offences are far too complicated and lengthy; the process moves slowly and the conviction rate is low. At least in the core of spurious drug offences, quick disposal and immediate/appropriate punishment is called for, as it would act as a true deterrent. It is therefore necessary to implement the Committee’s recommendation that a provision should be made under Drugs and Cosmetics Act to empower the State and Central Governments to constitute special courts for the trial of offences committed under the Act.

30.             Fifthly, the Mashelkar Committee notes that the functions of the officers of the regulatory system are mostly of a technical nature, whereas the manufacture and sale of spurious drugs is a criminal activity that requires specialized training and skills as well as the help of the police. The Committee observed that under the present provisions of Drugs and Cosmetics Act, only a Drugs Inspector is authorized to file prosecutions. It was felt that whenever a spurious drug case is detected and investigated by the police, they should also have the power to prosecute independently. It is therefore necessary to implement the Committee’s recommendation that the police also be authorized to file prosecutions.

31.             That the Petitioner understands that a bill to implement the recommendations of the Mashelkar Committee Report had been introduced in the Lok Sabha in December 2003 as the Drugs and Cosmetics Amendment Bill, 2003. However, as per the information available on the following

 internet link of the Ministry of Parliamentary Affairs, Government of India  the said bill lapsed on the dissolution of the XIII, Lok Sabha in terms of Article 107(5) of the Constitution. Thereafter a new bill (the Drugs and Cosmetics Amendment Bill, 2005) was introduced in the Rajya Sabha on 11.05.2005 but appears to have been placed in cold storage since.  

32.             That the recommendations of the Mashelkar Committee Report have still not been implemented, despite the repeated instances of tragedies in various parts of the country on account of the consumption of spurious drugs and the consequent violation of the fundamental guarantee of the right to life as enshrined in the Constitution of India.

Procurement of Spurious Drugs by Government Agencies

33.             The Respondent No.1 is unwittingly and without application of mind abetting the spread of spurious drugs through its procurement policy of buying life-saving drugs on the basis of lowest quotations. This Hon’ble Court in its judgement earlier referred, in People’s Union for Civil Liberties v. Union of India & Ors. reported at 105 (2003) DELHI LAW TIMES 937 (DB), had categorically frowned

upon the method and manner of procuring drugs and medical equipment. The focus in government procurement on procuring at lowest price at the expense of the quality of the drug has provided a ready avenue for manufacturers and suppliers of spurious drugs to access the market with large volumes of spurious drugs.  However, no action seems to have been taken by the Respondents pursuant thereto. In this regard reference is again invited to the article dated 28^th December, 2005 written by the petitioner, in the Business Standard. Relevant excerpts are reproduced hereinafter:

“However, without a change in the government procurement policy that buys life saving drugs on the basis of lowest quotations (L I) and not necessarily high qualitative standards, scores of government- run dispensaries and hospitals are flooded with medicines that are manufactured by shady outfits. The rates quoted by these so-called pharma companies are sometimes much lower than even basic raw material cost. It is, therefore, not surprising that established pharma companies find it difficult to compete. Most of them have even stopped bidding for government procurement orders.

The state of affairs in rural India, occupied by nearly 70 per cent of our population, is even worse due to lack of checks and balances.”

Copies of articles by the Petitioner in the Financial Express newspaper dated 10.06.2005 and in the Business Standard newspaper dated 28.12.2005 are marked and annexed  herewith as ANNEXURE A (Colly.).

34.             That as per various media reports, the manufacture and sale of spurious drugs continues unabated. It is reliably learnt that government hospitals, as a routine, procure medicines worth crores of rupees annually. Large quantities of such drugs which have expired are not properly destroyed and find their way into the hands of unscrupulous elements.  

35.             That the Respondents are also guilty of failing to issue or adhere to guidelines and rules pertaining to packaging and storing of drugs and medicines, especially with regard to the procurements undertaken by them. That since lowest cost is the single most important parameter in such procurements, safe packaging norms are neglected, thereby making the whole exercise of procuring medicine futile and self-defeating. A copy of an article, dated 29.04.2004, by the Petitioner published in the supplement of the Express Pharma Pulse, which throws more light on the subject, is marked and annexed herewith as ANNEXURE A hereto.

36.             Thus, till date i.e. more than three years after the publication of the Mashelkar Committee Report, the Respondent No .1 has been unable to implement the recommendations of the Committee pertaining to amendment of the Drugs and Cosmetics Act, 1940. Moreover, the Respondents have unwittingly played into the hands of spurious drugs manufacturers by procuring medicines on the basis of lowest quotations without paying heed to quality standards.

37.             The prayer(s) sought in this Public Interest Litigation ought to be allowed on the following grounds.

G R O U N D S

i.                        FOR THE REASON THAT the prevailing legal structure has failed to arrest the manufacture and sale of spurious drugs in India and their export to other countries.

ii.                         FOR THE REASON THAT the Respondents have, till date,  that is more than three years after the release of the Mashelkar Committee Report, failed to implement its recommendations.

iii.                         FOR THE REASON THAT this Hon’ble Court took cognizance of the prevailing and growing menace of spurious drugs which threatens the fundamental right to life under Article 21, in its judgment and order date 30.7.2003 in People’s Union for Civil Liberties v. Union of India & Ors. reported at 105 (2003) DELHI LAW TIMES 937 (DB).

iv.                         FOR THE REASON THAT the Respondents have, till date, almost four years after the date of the judgement and order of this Hon’ble Court in People’s Union for Civil Liberties v. Union of India & Ors. reported at 105 (2003) DELHI LAW TIMES 937 (DB), failed to implement the recommendation therein that “a suitable legislation be enacted so that severe punishment be given to people who   involved in the manufacture, distribution, trade and business of spurious drugs.”

v.                        FOR THE REASON THAT the fundamental right to life as enshrined in the Constitution includes the right to a healthy life and the Respondent Nos. 1 and 2 are duty bound to secure the same.

vi.                        FOR THE REASON THAT there is an urgent need to arrest the manufacture and sale of spurious drugs in India by implementing the recommendations of the Mashelkar Committee Report that penalties for offences related to manufacture and sale of spurious drugs be made more severe.

vii.                        FOR THE REASON THAT the Mashelkar Committee Report concludes that at present, persons engaged in the manufacture or sale of spurious drugs usually get bail and the prosecutions normally take about 10 to 15 years for decision. In many cases, the offender may get away with minor punishment whereas in all likelihood, he continues to indulge in spurious drug trade/manufacture during the period of trial. Therefore it is necessary that the Respondents implement the recommendation of the said Report that offences related to spurious drugs be made non-bailable, and that provisions similar to those in the Narcotic Drugs and Psychotropic Substances Act should be included in the Drugs and Cosmetics Act so that the Courts may consider applications for bail only after a period of three months.

viii.                        FOR THE REASON THAT the Mashelkar Committee Report concludes that sale of spurious drugs takes place almost always without bills and hence the penalty for dealers who are unable to produce authentic documents in support of their purchases should be made more stringent so that they exercise more diligence while procuring their drug supplies from unauthorized sources. It is therefore necessary, in order to stem the trade in spurious drugs, to implement the recommendation of the Committee Report to make the penalty for such offences severe.

ix.                        FOR THE REASON THAT the Mashelkar Committee notes that currently the legal proceedings in cases of spurious drugs-related offences are far too complicated and lengthy; the process moves slowly and the conviction rate is low. At least in the core of spurious drug offences, quick disposal and immediate/appropriate punishment is called for, as it would act as a true deterrent. It is therefore necessary to implement the Committee’s recommendation that a provision should be made under Drugs and Cosmetics Act to empower the State and Central Governments to constitute special courts for trial of offences under the Act.

x.                        FOR THE REASON THAT the Mashelkar Committee notes that the functions of the officers of regulatory system are mostly of technical nature, whereas manufacture and sale of spurious drugs is a criminal activity that requires specialized training and skills as well as help of police. The Committee observed that under the present provisions of Drugs and Cosmetics Act, only a Drugs Inspector is authorized to file prosecutions. It was felt that whenever a spurious drug case is detected and investigated by police, they should also have the power to prosecute independently. It is therefore necessary to implement the Committee’s recommendation that the police also be authorized to file prosecutions.

xi.                        FOR THE REASON THAT this Hon’ble Court has the jurisdiction under Article 226 of the Constitution to fill the vacuum or lacunae  in the prevailing legislative scheme to secure the ends of justice and protect the fundamental rights under the Constitution.

xii.                        FOR THE REASON THAT inaction on part of the Respondents in respect of tackling the life-threatening menace of spurious drugs is causing irredeemable pain and hardship among the public at large.

xiii.                        FOR THE REASON THAT the Respondent No. 1 being one of the largest procurers of drugs is duty-bound to ensure and secure the quality of the drugs so procured and is required to put in place proper regulations and mechanisms to ensure the quality of the medicines procured.

xiv.                        FOR THE REASON THAT the Respondent No. 1 under its current drugs procurement policy buys life saving drugs on the basis of lowest quotations (L I) and not necessarily high qualitative standards, as a result of which scores of government- run dispensaries and hospitals are flooded with spurious or sub-standard drugs. The rates quoted by these so-called pharmaceutical companies are sometimes much lower than even basic raw material cost. Many established pharmaceutical companies have even stopped bidding for government procurement orders for this reason, which allows a free hand to manufacturers of spurious drugs to pump large volumes of such drugs into the market, with tragic consequences for the general public.

xv.                        FOR THE REASON THAT despite numerous awareness campaigns and regular appeals and requests from the pharmaceutical industry, the Respondents have failed to check the spread of spurious drugs in India.

38.             That the Petitioner has filed this instant petition as an honest and aware citizen in the public interest. That the same has been filed bona fide and without any vested interest.

39.             That this Hon’ble Court has jurisdiction to entertain the present petition as the principal offices of the Respondent Nos. 1 and 2 are located within the territorial jurisdiction of this Hon’ble Court and part of the cause of action arises within the territorial jurisdiction of this Hon’ble Court.

40.             The Petitioner does not have any other alternate speedy and efficacious remedy available to it except to approach this Hon'ble Court invoking its extraordinary jurisdiction by way of the instant writ petition.

41.             That the Petitioner has not filed any Writ Petition on the same cause of action in this Hon’ble Court or in the Hon'ble Supreme Court of India.

P R A Y E R

In the premises it is most respectfully prayed that this petition may be allowed and this Hon'ble Court may kindly be pleased to:

a)      issue a writ in the nature of mandamus directing the Respondents to implement the recommendations of the Mashelkar Committee Report dated November 2003 to fill the lacunae in the penal regime for offences relating to spurious drugs;

b)         issue a writ in the nature of mandamus directing Respondent No. 1 to frame guidelines setting stringent quality control standards in government procurement of drugs to ensure that spurious or sub-standard drugs are not procured;

c)       issue such other writ, order or direction as may be deemed appropriate in the given circumstances; and

d)       allow costs of the Petition to the Petitioner.

PLACE: NEW DELHI

DATED:

                                                                             PETITIONER          

THROUGH

SETTLED  BY: AMIT SIBAL                             ALI  NAQVI 

                        ADVOCATE                                     ADVOCATE 

COUNSEL FOR THE PETITIONER