PATENTED DRUGS, COUNTERFEITING DRUGS, SPURIOUS DRUGSUNDER DRUG AND COSMETIC ACT AND IMPACT OF WORLD HEALTH ORGANIZATION-

A STUDY

Subject: Environment Law Submitted to: Maam Manpreet Kaur Submitted by: Jasween Singh Gujral 2008-27 4th year, 7th Semester

National Law University, Delhi

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TABLE OF CONTENTS
CHAPTER 1 INTRODUCTION RESEARCH METHODOLOGY RESEARCH PLAN CHAPTER 2 SALIENT PROVISIONS OF THE DRUGS AND COSMETICS ACT, 1940 FEATURES DRUGS AND COSMETICS (AMENDMENT) ACT, 2008 REGULATORY CONTROL OVER THE MANUFACTURE AND SALE OF DRUGS INITIATIVE TAKEN BY THE GOVERNMENT TO ENFORCE DRUGS AND COSMETICS ACT MORE EFFECTIVELY I. WHISTLE BLOWER SCHEME II. GUIDELINES FOR TAKING ACTION ON TEST REPORTS IN THE LIGHT OF ENHANCED
PENALTIES III. STRENGTHENING OF DRUG TESTING LABORATORIES

1 1 2 2 3 3 3 4 4 6 6 6 6 8 8 8 9 10 11 13 13 14 15 17 17 iii

CHAPTER 3 SPURIOUS AND COUNTERFEITING DRUGS SPURIOUS DRUGS THE EFFECT OF SPURIOUS DRUGS ON HEALTH OF PEOPLE: THE MASHELKAR COMMITTEE REPORT: COUNTERFEITING DRUGS CHAPTER 4 THE W.H.O. ON COUNTERFEIT DRUGS IMPACT OF W.H.O. AND INDIAN PHARMACEUTICAL INDUSTRY. CONTROVERSIAL ELEMENTS IN THE DEFINITION CHAPTER 5 CONCLUSION BIBLIOGRAPHY

CHAPTER 1 INTRODUCTION A Patent is a form of Intellectual Property Right granted and protected under the law. It is an exclusive right granted to a person who has invented a new and useful article or an improvement of an existing article or a new process of making an article. 1 The question as to whether a particular invention is new and useful is extremely difficult to decide and has to be determined based on the prior art in the particular field which includes publications on the subject as well as prior usage. The term patent originated from the Latin term literae patentes (letters patent) which means open letters.2 The origin of patent law in India can be traced back to the law and practice on patents in the United Kingdom. The pharmaceutical industry also incurs huge amounts of capital and toil in producing a product; therefore, the law is obliged to grant a patent on their medicines. But, a patent granted on a pharmaceutical product is largely different from any industry. Since, these may be life saving products a patent so granted comes directly in conflict with the interest of the general masses, as the life of the people and the incentive of the patentee has to be balanced. This opens the floor to a plethora of contentions flowing strongly from both the sides. This also gives rise to concepts such as generic drugs, counterfeiting drugs, spurious drugs. The aim of the paper is to put forth the impact of such drugs on the consumer, manufacturer and look into the government regulatory system and policies.

1 Jean O. Lanjouw, THE INTRODUCTION OF PHARMACEUTICAL PRODUCT PATENTS IN INDIA: HEARTLESS EXPLOITATION OF THE POOR AND SUFFERING?, Economic growth center, Yale university, p 5 2 ibid, p5

2 Research Methodology The researcher has adopted the doctrinal form of research in making this project. Primary as well as secondary sources of information have been used from the NLU Law Library. The above category of material includes a number of books related to Intellectual Property rights. Moreover the source from the Internet has also been widely.

Research Plan The researcher aims to put forth a clear picture of the definition, peculiarities, and difference between the kinds of drugs. The researcher would then focus on the various conflicting interests of the consumers, manufacturers and that of the State and also the impact of such drugs on the three parties. All this shall be done under the light of the Drugs and Patents Act, 1940 and WHO guidelines.

3 CHAPTER 2 SALIENT PROVISIONS OF THE DRUGS AND COSMETICS ACT, 1940 In 1937 a Bill was introduced in the Central Legislative Assembly to give effect to the recommendations of the Drugs Enquiry Committee to regulate the import of drugs into British India. This Bill was referred to the Select Committee and the Committee expressed the opinion that a more comprehensive measure for the uniform control of manufacture and distribution of drugs as well as of imports was desirable. 3 The Central Government suggested to the Provincial Governments to ask the Provincial Legislatures to pass resolutions empowering the Central Legislature to pass on Act for regulating such matters relating to control of drugs as fall within the Provincial sphere. Provincial Governments got the resolution passed from the Provincial Legislatures and sent them to the Central Government for getting through the Bill to regulate the import, manufacture, distribution and sale of Drugs and Cosmetics. Thereupon the Drugs and Cosmetics Bill was introduced in the Central Legislative Assembly.4 Features The manufacture and sale of drugs is a licensed activity under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. The licensees are required to comply with the provisions of the Act, Rules and the condition of the licence granted to them by the licensing authorities for manufacture and sale of drugs.5 The Drugs and Cosmetics Act, 1940 have elaborate provisions to check the production of spurious and substandard drugs in the country. The Act provides elaborate definitions of the terms spurious, adulterated and misbranded drugs for the purpose of taking penal actions against the offenders

3 Drugs and Cosmetics Act, 1940 - Introduction http://www.medindia.net/indian_health_act/drugs-andcosmetics-act-1940-introduction.htm#ixzz1eVp1lsXC 4 ibid 5 Vijay Malik, Drugs And Cosmetics Act 1940, 1ST ed, Reprint 2008, Eastern book Company, p448

Drugs and Cosmetics (Amendment) Act, 2008 The Drugs and Cosmetics Act, 1940, has been recently amended under the Drugs and Cosmetics (Amendment) Act, 2008 providing very strict penalties for manufacture of spurious and adulterated drugs. It is provided that any drug deemed to be adulterated or spurious when used by any person for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body as would amount to grievous shall be punishable with imprisonment for a term which shall not be less than ten years but which may extend to imprisonment for life and shall also be liable to fine which shall not be less than ten lakh rupees or three times value of the drugs confiscated, whichever is more. The fines realized in such cases will be paid to the relative of the deceased or the aggrieved person.6 Any drug deemed to be spurious but not being a drug referred to above shall be punishable with imprisonment of a term which shall not be less than 7 years but which may extend to imprisonment for life and with fine which shall not be less than 3 lakh rupees or three times the value of the drugs confiscated, which ever is more. Offences relating to sale and manufacture of spurious and adulterated drugs have now been made cognizable and non bailable. It has been provided that besides an Inspector appointed under the Act, the person aggrieved or consumer associations, a gazette officer authorised by the Government have also been authorised to launched prosecution under the Act. A provision has been made for especially designated courts for trial of offences under the act. A provision for compounding of minor offences has also been introduced. Regulatory control over the manufacture and sale of drugs Regulatory control over the manufacture and sale of drugs is exercised by the State Licensing Authorities appointed by the State Governments, which are responsible for
6 supra 5

5 monitoring the quality of drugs moving in the market. As a part of their function, the Inspectors appointed by the State carry out market surveillance by drawing samples from the sales establishments, hospitals and manufacturers and get them tested at governments' laboratories. Wherever a drug is declared as spurious or adulterated or not of standard quality, prosecutions are launched against offenders in the court of law by the concerned regulatory authorities depending upon the merits of the case. Being an undercover activity, it is difficult to detect the manufacture or movement of spurious drugs except by continuous surveillance by the State Drug Control Organization and active cooperation from the law and order Enforcement machinery in the State and other stakeholders like drug manufacturers associations and voluntary associations. A Drug Inspector appointed by the respective Governments is required to inspect not less than once a year all establishment licensed for manufacture or sale within the area assigned to him and to satisfy himself that the conditions of license are being observed. He may draw samples of a drugs or cosmetics from the manufacturing or sale premises, where he has reason to doubt the quality of drug, in a prescribed manner and send them for test and analysis to the Government analyst to check the quality. The manufacturer is also required to allow an inspector to inspect all registers and records maintained by him and to take samples of manufactured products, if required, and provide such information as required for the purpose of ascertaining whether the provisions of the Act and Rules thereunder have been observed. One or more inspectors to examine the premises, plant, appliances and process of manufacture, professional qualifications of technical staff and capability of the manufacturer to comply with the requirements of Good Manufacturing Practices and requirements of plant and equipment before a license is granted may conduct the inspection.

6 Initiative taken by the Government to Enforce Drugs And Cosmetics Act More Effectively i. Whistle blower scheme7 Whistle Blower Scheme has been announced by Government of India to encourage vigilant public participation in the detection of movement of spurious drugs in the country. Under this policy the informers would be suitably rewarded for providing concrete information in respect of movement of spurious drugs to the regulatory authorities. ii. Guidelines for taking action on test reports in the light of enhanced penalties8 In the 40th meeting of Drugs Consultative Committee (DCC) consisting of the DCGI and all State Drug Controllers held on 29.6.2009, guidelines for taking action on samples of drugs declared spurious or not of standard quality in the light of enhanced penalties under the Drugs & Cosmetics (Amendment) Act, 2008 were adopted for the purpose of uniform implementation of the Drugs and Cosmetic Act in the country. The guidelines with approval of the Ministry of Health were forwarded to the State Drugs Controllers for information and compliance. The guidelines have also been placed on the web site of CDSCO (www.cdsco.nic.in). iii. Strengthening of drug testing laboratories9 Under a Capacity Building Project through World Bank, assistance was provided to upgrade testing facilities and to establish new drug testing laboratories in the country so as to enhance the capacity of the laboratories to test large number of samples. Under this project 23 States and 6 Central Drug laboratories have been strengthened through renovations, extensions and equipments.

7 Ministry of Health & family Welfare, Reward Scheme for whistleblowers in the fight against the menace of spurious or fake drugs, cosmetics and medical devices: http://cdsco.nic.in/spurious_drugs.htm 8 Justice P. S. Narayana, Drugs & Cosmetics Act & Rules, 1st ed, Asia Law House, p 355 9 ibid

7 It is expected to increase the number of samples tested in the country from about 36,000 samples to 1,00,000 samples per year and to reduce the reporting time to less than a month as against the present period from 3 to 6 months.

8 CHAPTER 3 SPURIOUS AND COUNTERFEITING DRUGS

Spurious Drugs The drugs and food are essential components of the health care of the public. The recovery of ailing patients from illness is directly related to the quality of drugs they consume. The proliferation of spurious drug in India is a serious problem for the health of the people and there is an urgent need to curb it. India has made a commendable progress in the field of medicine, surgery and the manufacture of pharmaceutical preparations, generic drugs and the incipient.10 The pharmaceutical companies in India can be compared with any of the companies in advanced countries. The total turnover of the pharmaceutical companies for domestic market is estimated to be around 20000 crores11. The export is estimated to be around 11000 crores (2). 12 The illegal production of spurious drugs, cosmetics, food preparations and raw materials like spices has always been part of the trade in India. Recently, due to large volume of sales of pharmaceuticals and a lucrative business, an illegal production of spurious drugs have also started on an alarmingly large scale. According to World Health Organisations. WHO, 2001 statistics, 35% of the worlds spurious drugs are produced in India, followed by Nigeria at 23%.13 According to official estimates, the spurious drugs worth nearly Rs 4000 crores, which is 20% of total domestic pharmaceutical business, is manufactured in India.14 Fake drugs are an international phenomenon and they constitute 15% of the international market
15

Africa and Latin America have already started to complain about the import of spurious

10

S K Jain, THE SPURIOUS DRUG MENANCE & REMEDY, Health Administrator Vol : XIX Number, p 29 11 Peoples Democracy, Vol XXVII, pd.cpim.org/2003/0727/ 7272003_fmrai_drugs.htm 12 ibid 13 The Hindu, www.hinduonnet.com/thehindu/ seta/2003/07/31 14 ibid 15 The Tribune, www.tribuneindia.com/2003/ 20030709/health.htm

9 and sub- standard drugs from India. Since nearly 3-5% of the drug import in USA is spurious, USA has already put India in 301-watch threat list a few months ago.16 If India is found guilty of exporting spurious drug; USA would totally ban import of drugs from India.17 It is high time that India should take concrete steps to neutralize the spurious drug racket and especially in the export market in order to uphold the high image and to safeguard the interests of genuine manufacturers and traders. The Effect of Spurious Drugs on Health of People: It is difficult to ascertain a precise effect of a spurious drug on health of a person for the following reasons:18 a. It is not known at the time of consumption of medicine that it is a spurious drug. Therefore, if the drug is not effective a patient usually thinks that the diagnosis is wrong and either he consults another physician or ends up having a series of diagnostic tests including x-rays, ultra sound, MRI etc. resulting in an increased medical expenses, mental agony and absence from work or studies. b. If there are certain toxic effects of the medicine then it is usually assigned to an allergic reaction of the medicine and the physician might change the medicine. The toxic medicine is then completely forgotten and is not pursued any further. c. If the medicine is fatal then usually the death is assigned to the disease or the negligence of a doctor or the hospital Even when spurious drugs do not endanger life19 they can leave the patient seriously ill and those with inadequate potency can induce drug resistant bacteria i.e, they will not respond even when right medicine in right dosage is given. We come across hundreds of such cases in every day life. However there is a lack of
16 17

supra 15 supra 11 18 supra 11 19 supra 15

10 awareness of the existence of spurious and adulterated medicines by a large section of people and therefore the people, doctors and hospitals are not adequately alert. The public administration lacks the competence and the will to deal with the menace and moreover unless the moral standards of administration and politicians are high one The Mashelkar Committee Report: The Mashelkar Committee report 20 submitted to the Union Health Ministry on August 12, 2003, advised strong action against those manufacturing and selling spurious drugs. Dr R A Mashelkar, Director General, Council of Scientific and Industrial Research (CSIR) and Scientific Advisor to the Prime Minister, made the following recommendations in the report. Upgrading the Central Drug Standards Control Organization (CDSCO) to monitor the menace should form a Central Drug Administration (CDA). The penalty for manufacture and sale of spurious drugs should be enhanced from five years to not less than seven years. The maximum penalty for manufacture and sale of spurious drugs causing grievous hurt or death should be enhanced from life imprisonment to death. 21 A provision should be made in the Drug and Cosmetics Act declaring all offences related to spurious drugs as cognizable and non- bailable. A fine of Rs. One lakh or up to three times the worth of the spurious drugs held by a seller should be charged . 22 Police authorities and drugs inspectors should be authorized to file prosecutions under the Drugs and Cosmetics Act. A separate provision should be made for speedy trials of such offences. No court lower than a Sessions court should try these offences. State governments should strengthen and support their drug control organizations. Industry and trade associations should play an active role to arrest the menace.

20 21

http://cdsco.nic.in/html/mashelkar.html supra 11 22 http://www.healthlibrary.com/news/ March2003/24-29 March 2003/Spurious.htm

11 Counterfeiting Drugs Numerous organizations have been trying to arrive at a workable definition of the term "counterfeit drug." Common violations of regulations include look-alike products that contain little or no active ingredient and possibly contain harmful ingredients, rejects that have been kept off the market by the manufacturer or regulatory authorities for quality reasons, and relabeled medications that have expired but have been repackaged and remarketed with a much later expiration date. Less common are identical copies, or counterfeit products manufactured with the same ingredients, formulation, and packaging.23 The development of a new original drug typically takes about 10 to 12 years and can cost as much as $ 1.5 billion.24 Each year, worldwide, only about 26 new chemical entities drugs enter the market. 25 These figures prove beyond doubt that pharma companies have a difficult road ahead for drug development. Hence, their investments in resources, time and research should be aptly rewarded by allowing them a monopoly in the form of patent protection for a stipulated period of time. This provides the R&D teams an innovators prize for helping the patients to combat the diseases with latest drugs and also helps to maintain the vicious circle of finance to R&D and vice versa to further come up with new drugs. However, once the term of patent or associated marketing rights expires; other manufacturers are free to come up with generic versions of these drugs. On the other hand, a generic drug is identical to and bioequivalent of a branded drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use which US Food and Drug Administration (FDA) also confirms. Respective countries have intensive procedures for drug approval wherein various generic versions also have to meet the stringent criteria in the same way as innovative drugs. The most important advantage with generic drugs is that they are cheaper as no R&D investments are involved as in the case of new drugs. The prevailing
23

http://www.medscape.com/viewarticle/465906_2 24 Adams C, Brantner V, Estimating the cost of new drug development: Is it really 802 million dollars? Health Aff (Millwood), 25 (2) (2006) 420-428. 25 DiMasi J A, Hansen R W, Grabowski H G, The price of innovation: New estimates of drug development costs, Journal of Health Economics, 22 (2) (2003) 151-185.

12 fierce competition also makes the manufacturers keep to low prices. Thus, generic versions help patients by making the drugs available at affordable prices while retaining the quality. In other words, generic drugs balance public interest especially in diseases like cancer and AIDS, the prevalence of which is very high, that too in developing countries and treatment with patented drugs is steeply priced. With a five-year extension being granted to the President's Emergency Plan for AIDS Relief (PEPFAR) in August 2008, the Wall Street Journal has noted that much of the $ 131 million funding is spent on generic drugs.26 This is a marked departure from PEPFAR's earlier and heavily criticized practice of purchasing only expensive, patentprotected and branded drugs. An estimated half of all prescriptions in the United States are now filled with approved generic drugs, which brings out their escalating importance.

26 http://online.wsj.com/article/SB121746894789699503.html

13 CHAPTER 4 THE W.H.O. ON COUNTERFEIT DRUGS Recently, fate of generic industry was at stake when WHO defined counterfeit drugs as: A medicine which is deliberately and fraudulently mislabelled with respect to identity and/or source.27 Counterfeiting can apply to both branded and generic products and counterfeit products may include products with correct ingredients or with wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging 28 , thus, covering even generic drugs under the warp of counterfeit drugs. WHO estimates that while less than 1% of the drug supply in industrialized nations including the US is potentially counterfeit, it is to the tune of 10-30% for the countries having less legal or regulatory oversight? There is, however, no exact or speculated data to predict likely prevalence of counterfeit drugs in particular geographic areas of the world. WHO released a Report in 2006 describing counterfeit medicines as a global health crisis. Whatever be the magnitude of presence of counterfeit drugs worldwide, it can be unequivocally said that they have to be curbed in public interest. Numerous anticounterfeiting initiatives have recently been launched for example, the AntiCounterfeiting Trade Agreement (ACTA) (a plurilateral initiative of the European Union, Japan, United States and Switzerland), World Customs Organization on Provisional Standards Employed by Customs for Uniform Rights Enforcement (SECURE), G-8 Countries' Initiative on Counterfeits; WIPO's Advisory Committee on Enforcement (ACE), Security and Prosperity Partnership (SPP) (between Canada, Mexico and US). Besides these localized efforts, globally acceptable pharmaceutical norms and standards are also required as pharma products are being marketed internationally, with advent of globalization. Such international norms may serve as a gold standard to ensure safety and quality of medicines. To address the problem of counterfeiting on global front, an

27

Nitin Shukla and Tanushree Sangal, Generic Drug Industry in India: The Counterfeit Spin, Journal of Intellectual Property Rights Vol 14, May 2009, pp 236-240 28 http://www.who.int/medicines/services/counterfeit/overview/

14 international consensus on quality, safety and efficacy standards for the distinction between generic and counterfeit drugs is of paramount importance. This would also help speed up access to medicines. However, it is worth noting that, there is no consensus among the member nations as to what actually are counterfeit drugs. In general, the member States of WIPO rely on WHO guidelines, standards and norms for regulation, safety and assurance of quality of medicines. WHO provides relevant expertise and technical assistance to members through activities such as guideline development, workshops and training courses, coordination and promotion of anti-counterfeiting measures, prequalification of medicines for priority diseases, pharmacovigilance for global medicine safety and regulatory and other information exchange? The trend of member nations relying on the definition provided by WHO in case of drug specifications might be applicable in the case of counterfeit drugs also. This entrusts the WHO report with greater responsibility, as not only does it affect the fate of diseased millions, but might also adversely affect the pharma industry across the globe. Impact of W.H.O. and Indian Pharmaceutical Industry. The detrimental impact of this description of counterfeit drugs on Indian generic industry is very emphatic as situations here are also paradoxical. India on one hand has been identified as one among several developing countries that are regarded as the source of counterfeit medicines by the Oorganization for Economic Cooperation and Development (OECD).29 On the other hand, India's largest generic drug manufacturer, Ranbaxy30, remains on FDA's list of companies producing generic antiretroviral drugs approved for PEPFAR. It is also worth noting that India is the fourth largest producer of pharmaceuticals in the world, which accounts to 8% of worlds production by volume and 1.5% by value. 31

29 http://www.outsourcing-pharma.com/Contract-Manufacturing/ New-counterfeit-report-highlightsworrying-trends. 30 http://www.pharmaceutical-drug-manufacturers.com/articles/top-10-pharmaceutical-companies-inindia.html 31 supra 28

15 Indian pharmaceutical industry ranks 17th in terms of export value of bulk actives and dosage forms. India exports its products to more than 200 countries around the globe including highly regulated markets of US, Europe, Japan and Australia.32 The situation becomes even more decisive for India as according to Goldman Sachs study, it is estimated that India is estimated to be the fifth largest pharmaceutical market in the world by 2020, with sales of US$43 billion.33 Due to various reports as aforesaid regarding India as a source of counterfeit drugs, the WHO definition has been inviting contempt from the Indian pharmaceutical industry. Controversial Elements in the Definition The Indian pharmaceutical manufacturers and officials have assailed the word history, as it is considered to be ambiguous and capable of acting as a market barrier for exports to countries. The exposition has also made industry experts and stakeholders to emphasize that it goes beyond the issues of quality, safety and efficacy and could be used as a contrivance to project India as a center of substandard and counterfeit drug production. 34 The most controversial part of the definition is that any false representation in relation to identity, history or source would be considered a case of counterfeiting. False representation of identity and source applies not only to mere labeling of the products, but also to its container or other packaging. Thus, false representation with regard to any of those elements would make the product counterfeit within the scope of the definition. This brings trademark issues also into play. The fake packaging and counterfeiting at local levels need to be checked through enforcement of IPR mechanisms. Trademark owners have strong incentives to ensure that the quality of their product is maintained. If trademarks are not enforced, substandard drugs or counterfeits would sideline the genuine ones.
32 http://www.directories-today.com/drugs.html. 33 ibid 34 supra 28

16 It must be noted, that though trademark enforcement in developing nations is lacking in vigour, it is not entirely impossible to cloak the rights holders as well as administrative authorities with powers to check the menace. However, all differences in packaging may not be fraudulent. Sometimes, the difference in shape, colour schemes or packaging, may arise on account of batch to batch variation. Under the definition as currently worded, such drugs may be regarded as counterfeit despite having appropriate active pharmaceutical ingredients since it covers both branded and generic products under its ambit. Concerns have been raised that this could lead to India's authorized exports of genuine drugs being termed spurious. Another factor deserving attention is that a medicine would be considered counterfeit according to the present explication, if, by no fault of the exporters, the medicine is smuggled into a different foreign destination. By necessary implication, if medicines originally intended for one country end up in another country where they are not registered, they would be declared fake.

17 CHAPTER 5 CONCLUSION Indian Generic drug industry supplies life saving drugs to the poor countries and other developing nations. It is a boon for people who are fighting with diseases like HIV/AID, diabetes, cancer and cannot afford to pay high prices for them. Generic versions of branded drugs are boon for them. In spite of various challenges to the generic pharmaceutical sector, it continues to shine. Indian law on patents have been interpreted by Indian Judiciary in keeping the interest of poor and needy in mind. It has made sure that the economic and social aspect of the law is protected and the western big pharmaceutical are not allowed to play monopoly here. The responsibility to check the menace rests with the Government. The appointment of expert committee under the chairmanship of Dr R A Mashelkar shows their concern. The committees recommendations are given above. Simply enhancement of penalty is not going to trap the culprits. The concerted efforts are required by drug control officers to nab the culprits. Since it is difficult to establish that the spurious drug is responsible for the grievous hurt or death, the introduction of death penalty is not going to make much difference to these criminals. The suggested fine is just a peanut to them. The Government should educate people through electronic media regarding the circulation of spurious drugs and the danger they pose to the health. The Government should declare fabulous prizes for the informers, whose information may lead to nab the culprits. The genuine pharmaceutical companies should upgrade the technology, from time to time, for packing their products as to have a lead over the spurious drugs manufacturers, which copy the technology as then there will be a lag time before the latter can acquire the innovation. They should use holograms, bar-code, special inks for printing, printed/locked capsules, embossing logo on the tablets, pilfer proof packing etc to make it difficult for the small spurious drugs manufacturers to copy. They should

18 emboss month and year of the date of manufacture or at least the year on glass bottles to stop recycling of the bottles. The harmonization of the definition of counterfeit medicines is essential to avoid genuine generic medicines being considered counterfeit - a term normally associated with illegally produced or supplied medicines that may or may not conform to quality specifications. India has stressed that a generic or branded medicine not registered in a particular country, but available in that country is not counterfeit, but simply an unregistered product. False representation would also allow quality defects and system errors in manufacturing process to be tagged as counterfeiting. All these factors demand a due consideration of the definition, before it is universally applied.

iii Bibliography Jean O. Lanjouw, THE INTRODUCTION OF PHARMACEUTICAL PRODUCT PATENTS IN INDIA: HEARTLESS EXPLOITATION OF THE POOR AND SUFFERING?, Economic growth center, Yale university,

Vijay Malik, Drugs And Cosmetics Act 1940, 1ST ed, Reprint 2008, Eastern book Company.

Nitin Shukla and Tanushree Sangal, Generic Drug Industry in India: The Counterfeit Spin, Journal of Intellectual Property Rights Vol 14, May 2009

DiMasi J A, Hansen R W, Grabowski H G, The price of innovation: New estimates of drug development costs, Journal of Health Economics, 22 (2) (2003)

Adams C, Brantner V, Estimating the cost of new drug development: Is it really 802 million dollars? Health Aff (Millwood), 25 (2) (2006) 420-428

Justice P. S. Narayana, Drugs & Cosmetics Act & Rules, 1st ed, Asia Law House