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Petition Submission on Spurious Drugs by PSM India before the Committee on Petitions

Petition Submission on Spurious Drugs by PSM India before the Committee on Petitions



Submission before the Committee on Petitions
On the
Petition submitted by Shri Rahul Gaur, a resident of NOIDA, U.P. praying to put a check on manufacture of Spurious Drugs in our country and other related issues


We are very glad to learn that the Committee on Petitions of the Rajya Sabha is examining various issues relating to Spurious Drugs in response to the Petition submitted by Shri Rahul Gaur of Noida.
Consumer Online Foundation (COF) is a registered not-for-profit TRUST which has been working on various Consumer Issues since 2003 with Government of India and other international non-governmental organisations and is a member of Consumer Coordination Council, a National Coalition of more than 70 leading Consumer Organisations of the country. COF has implemented and conceptualised several projects for the Ministry of Consumer Affairs, Food & Public Distribution, Ministry of Health & Family Welfare and Ministry of Chemicals and Fertilisers and also founded several important projects for the development sector with focus on consumer’s Right to Quality and Safety in Healthcare related activities.
In December 2010 COF founded “Partnership for Safe Medicines (PSM) India” www.safemedicinesindia.in . PSM India is the first global partner organization of the Partnership for Safe Medicines, and was established to educate consumers and identify and implement meaningful solutions to address the global concerns on spurious and unsafe medicines. P. S. M. India comprises of more than a dozen organizations representing patients, experts, consumer organisations and the medical community. The goals of PSM India are:


• To raise public awareness of the harms to patient safely caused by spurious and not-of-standards medicines
• To inform consumers and distributors of medicines in the community, the existence and extent of spurious and unsafe medicines problem in the supply chain in India
• To work collaboratively with the medical community
• To educate and empower Indian consumers on the importance of medicine quality and safety, how to identify suspected spurious medicines, and what actions to take when they encounter a suspected case of unsafe medicine
• To educate community healthcare practitioners in retail outlets and healthcare centers on the problem of spurious medicines and what role they can play to lessen the problem by working in a collaborative manner with the law enforcers.
As part of the coalition’s efforts, PSM India operates a toll-free helpline (1800-11-4424) that consumers can call if they have questions, sound alerts incase of they have received a spurious medicine or to report an incidence of sub standard medicines being sold. PSM India is becoming a trusted go-to resource in India that can help consumers, medical professionals, pharmacists and the government navigate the increasingly complex and dangerous world of spurious and not-of-standard medicines.
P. S. M. India has had several rounds of discussions in the Board Meetings Chaired by persons like Mr. Ashok Kumar, IAS (Retd.), Secretary to the Government of India and the present Chairman of PSM India Shri Wajahat Habibullah IAS (Retd.) Secretary to the Government of India and former Chief Information Commissioner, on various issues relating to prevalence of Spurious medicines in the country and the measures necessary to meet the challenge. In the light of these discussions we are submitting our comments on the subject as follows:
The act of manufacturing Spurious and unsafe medicines is a criminal activity and is governed within the existing laws of our country, especially the law on Drugs and Cosmetics Act 1940. This can happen in the organised and unorganised sector of pharmaceutical manufacturers or a one off episode manufacturer, hence becomes a challenge to catch the culprits. It is also known to be a highly organised and sophisticated operation conducted globally in connivance with several players, who indulge in criminal activities and having links with cross boarder terrorism and smuggling. Manufacture and sale of spurious and unsafe medicines is primarily a clandestine activity. It is therefore difficult to identify the manufacturers and distributors of spurious medicines unless the countries agree to come together to fight this menace, which plays with the health and safety of the citizens.  Any effective action against this activity would require continuous surveillance by the regulators and law enforcers globally as part of the global intelligence service with active co-operation from all the stakeholders like pharmaceutical industry, consumer organisations, healthcare practitioners and the members of the United Nations.
Spurious, not of Standard and Unsafe Medicines have raised a global outcry from patient’s groups and consumers due to several media reports and lack of prompt regulatory intervention, which has created doubts and mistrust in the existing supply chain in countries like India. India has of late emerged as one of the leading countries in the world to manufacture and supply medicines globally to enable citizens to access quality medicines at the most affordable price.
The issue of counterfeit medicines is invariably debated with emotive concerns rather than factual understanding of the situation. The very fact that it is a matter of serious concern, since it relates to all sections of the society, makes it an imperative need to quantify the problem and then devise strategies appropriate to the extent of spurious medicines in the various supply channels to eliminate the menace.
The media had been projecting problem of spurious medicines in the country in a manner which does not provide a balanced picture and has, therefore, caused serious apprehension. The issue of spurious medicines gets debated with a lot more emotive content than factual understanding of the situation.  It is more than likely that the quoted facts, stories and statistics which feed on each other,  has resulted in distorted and exaggerated projections, which further confuses the citizen-consumer.
Thus due to misplaced apprehensions about the availability of safe and genuine medicines in India, concerns are raised not only by the consumers within India but  also globally, which is affecting the credibility of medicines manufactured in India. This could also be a deliberate campaign to undermine the quality of medicines manufactured in India because of the competitive nature of Indian medicines and also because India is emerging as one of the leading exporters of pharmaceutical products globally.  
In India, in the recent times, there have been two major studies relating to Spurious Drugs. The first was by SEAR Pharma Forum (FIP/WHO Forum of National Pharmaceutical Association) and the Second by CDSCO (Central Drugs Standard Control Organisation). Both the studies attempted to estimate the extent of counterfeit (spurious) medicines circulating in Indian Market.

  • The survey funded by WHO & carried out by SEAR Pharma Forum in 2007 showed 3.1% counterfeit suspects during visual inspection but 0.3% did not meet the pharmacopoeias standards during laboratory analysis.
  • ‘Countrywide Survey for Spurious Drugs’ was carried out by CDSCO in 2008-09 based on statistical methodology of determining the sample size advised by Indian Statistical Institute, Hyderabad. According to the report, extent of spurious/counterfeit was around 0.05 per cent (11 samples were not accepted by the respective manufacturers out of 24,136 collected samples).

As against the above findings

  • The counterfeit medicines trade is believed to be 30 to 40 percent of total market as focused by the media.
  • Data generated on the legal samples drawn by Drugs Inspectors throughout India shows the extent of spurious drugs vary between 0.3 to 0.4 %

Whom to believe and what to believe? It will be seen from the position indicated in the two studies quoted by us that neither the survey by WHO nor by CDSCO appeared to reflect the apprehended fears of a far larger extent of prevalence of Spurious Drugs. PSM India has therefore in consultation with all the stakeholders has prepared a draft methodology, which will try to further address the issue of data collection on spurious medicines in the supply chain in India and bridge the gap in order to arrive at the exact extent of the menace of spurious medicines and remedies to eliminate the unsafe medicines from the supply chain for good. The outcomes from the draft methodology has highlighted the need for carrying out  a more credible and  comprehensive study much larger than the earlier studies with a wider coverage to reach the various outlets in the supply chain and get into the deep pockets of distribution and hotspots of the Indian Market. The present day complexities in the distribution system allow several entry points for spurious medicines into the system. More often the products are bought and sold at 5 or even more times by C&F agents, wholesalers, super-stockists, stockists, sub-stockists, transported by different modes of delivery before they reach a retail pharmacy and eventually the patients. Understandably this secondary market is vulnerable to unscrupulous endeavours of unethical traders and criminals. Moreover illegally imported stolen, spurious or adulterated drugs have an easier access to distribution systems through secondary market. On top of this, free availability of medicines without prescription has led to proliferation of spurious medicine.
Often doubts have been raised about safety to patients due to spurious medicines as the spurious medicines may not contain labelled drug with specified content or contain different drug or whose source is different to one declared and hence patient may or may not get the desired therapeutic benefit. Therefore it is essential to define the scope and definition of spurious medicines and differentiate between spurious and sub-standard medicines.
Since the access to essential medicines and rational use of drugs is a major issue, to ascertain the extent of prevalence of Spurious Medicines in the supply chain, the focus has to be on medicines selected out of a list of 348 essential drugs listed in the National Formulary of India, sold in the market. The intention should be to cover all the ten important therapeutic areas, branded and generics in different price levels.
Unsafe drugs could be

  • Spurious/counterfeit drugs,
  • Sub standard, sub therapeutic, unlicensed drugs
  • Drugs manufactured under improper condition (non compliance of GMP)
  • improperly stored drugs,
  • Having unfavorable benefit risk profile

The overall objective of a Drug Regulatory Authority (DRA) is to ensure that medicinal products are of acceptable quality and manufactured and distributed in ways which ensure their quality until they reach the patient/consumer, and their commercial promotion is accurate.
Consumers have the right to expect that Drug Administration will not just protect the public health by keeping unsafe drug off the market but facilitate the availability of safe and effective drug.
Spurious Drugs are mainly the products which are deliberately and fraudulently mislabeled and manufactured to mislead and misrepresent the patients by concealing their identity, source of manufacture and its content to profiteer on the popularity of fast moving branded or generic medicines. It may or may not contain the active ingredients in the manner mentioned on the label nor adopt good manufacturing practices to ensure patient safety and quality.


Sec. 17B of the D&C Act defines Spurious Drugs as

  • If it is manufactured under a name which belongs to another drug; or
  • If it is imitation of or is 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 unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or
  • If the label or container bears the name of an individual or company purporting to be 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.

In the light of the position as indicated above and as a sequel to the discussions with the Drug Controller General of India, PSM India organized a National Consultation on Developing the Methodology for a Proposed study on the extent of prevalence of Spurious Medicines in the Supply chain in India and related issues.
Based on the recommendations emerging from the Consultation meeting is attached as ANNEXURE I. We are in the process of further discussion with the Drug Controller General of India and the Ministry of Health & Family Welfare, Government of India to draw up a project for conducting a study based on a National Survey in consultation with all the stakeholders and the World Health Organisation, which has also initiated similar studies in other countries.
The Founder of PSM India was nominated a member of the Mashalkar Committee in the year 2003 representing Consumer Coordination Council as its Vice Chairman, He had the privilege of interaction with renowned experts and representatives of various professions and industry association, which provided us with a great insight into the issues concerning spurious and unsafe medicines in the supply chain in the country. Several excellent recommendations were forwarded to Government of India but unfortunately not many have got implemented till date. We are of the strong view that if each and every point of the report and recommendations are implemented in India then to a large extent the menace of spurious medicines can get eradicated. Take for example the formation of a robust Authority to tackle such regulatory issues and recruitment of several experts and scientific institutions to work on the subject will definitely strengthen the inspection and tracking mechanism. The Expert Committee had gone to the extent of Death Penalty to the persons caught manufacturing spurious medicines, which could be fatal to the life of the citizen. A roadmap was prepared based on the recommendations, which is yet to see the light of the day. We are pleased to attach the Executive Summary of the Mashalkar Report as ANNEXURE II, which would provide intellectual insight into the way forward and the mechanisms to be adopted in our country to protect the health and safety of the citizens.
On 17th November 2008 the Principal Scientific Advisor to the Govt. of India constituted a Working Group on “the Scientific and Technological Measurers to counter Spurious & Sub-standard Drugs and Diagnostic Centres”. The Working Group consisted of 9 Members including the Chairman Dr. P.N. Tandon, Emeritus Professor, AIIMS, which included the founder of PSM India who was at that point of time Executive Director of Consumer VOICE. The working group looked at several technologies and it was subsequently recommended to Government of India, Ministry of Health and Family Welfare but unfortunately again the recommendations were not implemented by the Government till date. However since the formation of PSM India since 2010, lots of activities have taken place to convince the Government to adopt the technologies and make them mandatory so that India has a robust tracing and tracking system for consumers to identify spurious medicines and buy only genuine generic or branded medicines from authorized retail stores or hospitals, which has the capacity to detect and authenticate the genuine medicines versus spurious or sub standard medicines. Several technology providers are already in India doing business with pharmaceutical companies but unfortunately the consumers are not empowered with the information nor is it made mandatory for all the medicine manufacturers in India to adopt the affordable technologies. The recommendations of the Tandon Committee are attached as ANNEXURE III.   
We look forward to the support of the Committee in taking up this important issue and support the proposed survey as a prelude to the further action to combat the menace of Spurious Drugs. We also recommend that all the recommendations of the Mashalkar committee should get implemented without any further delay. Finally the Dr. P. N. Tandon Committee Report on the adoption of technologies to detect and authenticate spurious medicines in India must get immediately mandated to ensure all medicines sold and manufactured in India must be serialized and stored in the custody of the Government to immediately trace and track the genuine medicines and alert consumers on spurious and sub standard medicines before the medicine becomes fatal and life threatening. Once again we wish to thank the members of the Parliamentary Committee on Petitions for taking up this critical issue to protect the health and safety of the patients. 

 

ANNEXURE I
Summary of the Proposed Methodology
All the stakeholders agreed that there are enough evidence of existence of spurious drugs in both the domestic and export markets. We should learn from the already conducted studies on India on the extent of spurious medicines in the supply chain.
The parameters of the existing studies were however circumscribed, and consequently, to a need to go beyond these studies – to go beyond their parameters and methodology. The proposed study should not be confined only to chemists; the net should be cast wide to cover all levels of manufacture, distribution and usage, and a deeper penetration encompassing rural areas, doctors and hospitals.
The proposed study must emphasise the need to cover both private and public hospitals, given that they make drugs and medicines available at their own premises. The study must recognise on the complexity of the problems involved in conducting a credible survey and the difficulty in tracking and tracing spurious drugs through the supply chain, which comprises wholesalers, regional and sub stockists and a huge number of retail outlets.
The study cannot ignore the fact that there is the existence of secondary markets, some of which are known to be indulging in the distribution of spurious drugs. The sale of medicines over the counter without a doctor’s prescription was another dimension of the problem, which made it difficult to keep track of drug-supply flows.
The proposed study also cover the aspect of distribution of drugs and medicines through CGHS, ESI, Army Hospitals, etc., as these institutions have very large distribution channels involving substantial numbers of patients.
The broad parameters of future studies on spurious drugs, according to the participants should cover:

  • Extent of spurious drugs involved in import & export.
  • Extent of spurious drugs in channels other than retail.
  • Extent of spurious drugs among the brands of relatively smaller manufacturers.
  • Extent of spurious drugs among the generic/INN (International Non-proprietary Name) products.
  • Extent of spurious drugs in relatively low sales turnover products.
  • Other dosage formulations i.e. injectibles, oral liquids, ointments etc.

The sample size of the medicines to be tested and the categories should be decided by experts on the subject, who have competence on conducting similar studies and must be trained for such purpose. It was also agreed that while this will be an all stakeholder’s ownership exercise, Government of India shall play an important role to ensure credibility and transparency in the study.
The resources for the study should be raised from all the stakeholders and Government of India should match the financial resource to ensure success and the conduct of the study and its outcomes.
It has to also zero down on all such spots and venerable locations, which are famous for such notorious activities like manufacturing of spurious medicines. It could also be considered that Rapid Testing Mechanisms could be used to identify spurious medicines quickly and then send them all for physical verifications at accredited laboratories.
This study must elaborate the most venerable points of contamination of the supply chain by traders of spurious medicines. We should not only look at ports but also post office dispatches.
The sample collection should be with the support from citizens, public/private hospitals, ports, post offices, various points of the supply chain to ensure active participation from reputed and credible institutions and citizens. It should be a massive exercise based on voluntary participation and become a successful public private partnership initiative for the coming years. All information must be made public and data verifiable by any agency or individual at a cost sharing basis.
The final agreed methodology must emerge from various consultations within the interested parties through email and thus seek inputs from public in an open manner. The agreed methodology should be once again deliberated in an open forum to ensure that the process is unbiased and scientifically tenable. All such technologies should be considered to be used, which would bring speed and enhance the study dimensions in terms of increase in sample size and accurate results.  

  
 
Annexure II

EXECUTIVE SUMMARY OF THE MASHELKAR COMMITTEE REPORT

1. There has been a wide-ranging national concern about spurious/counterfeit / substandard drugs. The Supreme Court of India, the National Human Rights Commission and the Members of Parliament have time and again expressed a concern about improving the drug regulatory system in the country. The Drugs and Cosmetics Act has not been reviewed in a comprehensive manner since its inception although the Rules have been amended from time to time. The Government of India, in the past, had
constituted several Committees, which had examined the issues and had made many recommendations. These recommendations have been implemented by the Government to some extent, but the core issues have remained unresolved.

2. The Government of India decided to constitute an Expert Committee under the chairmanship of Dr. R.A. Mashelkar to examine all the aspects regarding the regulatory infrastructure and the extent and problem of spurious/substandard drugs in the country. The Committee was asked to make recommendations and suggest a roadmap for implementation of the recommended measures so that this problem could be solved in its entirety. The Committee had an eminent scientist, an eminent lawyer, and former police commissioners as its members. Officials representing key Ministries/Departments/States/ drug manufacturers, trade, consumer and professional associations were also inducted as members. Drugs Controller General (India) acted as the Member Secretary.

3. The Committee examined the broader issues by looking at the recommendations of earlier committees, the extent of progress made and the bottlenecks in implementation of the recommendations. The Committee noted that while some measures had been initiated by the Central Government, much more needed to be done to improve the regulatory system. Further, the response to these issues at the State Government level was a matter of special concern.

4. The Committee noted that although the Drugs and Cosmetics Act has been in force for the past 56 years, the level of enforcement in many States has been far from satisfactory. The non-uniformity in the interpretation of the provisions of laws and their implementation and the varying levels of competence of the regulatory officials were the main reasons for this less than satisfactory performance.

5. The Committee noted that in the light of the assessment and the recommendations of several committees, the Ministry of Health & Family Welfare had made proposals for expansion and upgradation of CDSCO. Several posts to strengthen port offices, zonal offices and testing laboratories were also created. These posts could not be filled due to some administrative complexities. The posts have since lapsed. The committee understands that efforts were made to revive these posts but actual filling of the posts has not been done yet.

6. In 1999, the Pharmaceutical Research & Development Committee (PRDC)
had recommended comprehensive strengthening of CDSCO to enable it to carry out the multifarious activities that the Department was expected to perform. The Committee noted, however, that in spite of the fact that three years had lapsed from the acceptance of the PRDC report by the Government, no infrastructural improvement in respect of manpower had occurred in CDSCO.

7. The idea of setting up of National Drug Authority (NDA) starting with the Hathi Committee Report (1975) was reiterated by Drug Policy (1986), and Drug Policy (1994). However, it was not implemented.

8. The Committee concluded that the problems in the regulatory system in the country were primarily due to inadequate or weak drug control infrastructure at the State and Central level, inadequate testing facilities, shortage of drug inspectors, non-uniformity of enforcement, lack of specially trained cadres for specific regulatory areas, non-existence of data bank and nonavailability of accurate information.

9. The Committee concluded that the existing infrastructure at the Centre and States was not adequate to perform the assigned functions efficiently and speedily. The Committee felt that creating another authority will not solve the problem at hand. It was essential to strengthen the existing organisations to enable them to undertake all the functions envisaged for NDA. A strong, well equipped and professionally managed CDSCO, which could be given the status of Central Drug Administration (CDA) was the most appropriate solution. A detailed proposal to create such a structure and strengthen the State level regulatory apparatus with complementary roles of the Centre and the States, while at the same time ensuring uniform
and effective implementation, has been considered and recommended by the Committee.

10. The Committee noted that the onus of monitoring drug manufacturing standards, drawing and testing of samples, taking legal action against infringers rested primarily with State Drug Regulatory agencies. Hence for any effective intervention, it was essential that the State Governments strengthen and support their Drug Control Organizations. This will include provision of additional personnel, with top class technical and investigative skills, appropriate infrastructure and adequate resources. Despite several directions from the Central Government, many State Governments were yet
to upgrade the drug testing facilities and the competence of their regulatory infrastructure was not at the desired level.

11. The information collected from the States in response to a questionnaire
sent by the Committee revealed serious inadequacies of the regulatory apparatus. Out of the information received from 31 States/UTs, only 17 drug-testing laboratories were found to be functioning. Out of 17 States having their testing laboratories, only 7 were reasonably equipped/staffed, while the others were poorly staffed and did not even have the bare minimum equipment.

12. The Committee further observed that right from the time of Hathi Committee Report (1975), the States had been repeatedly requested to set up intelligence cum legal cell but so far only 10 States had reported to have set up such cells. It was not clear as to how many of these are really functioning actively and effectively.

13. The Committee was able to obtain detailed information regarding different categories of manufacturing units licenced by the State authorities. It was found that as against the frequently quoted figure of about 20,000 manufacturing units. The actual number of drug manufacturing licenses issued was - bulk drugs (1333), formulations (4534), large volume parenterals (134) and vaccines (56). Thus, the total number of manufacturing units engaged in the production of bulk drugs and formulations is not more than 5877. Besides there are 199 medical devices units, 638 surgical dressings and 272 disinfectant units, 4645 loan licences and 318 repacking units, 1806 blood banks, 2228 cosmetics units and 287other units not covered in the above categories.

14. The Committee examined the various reports and statistics presented at various fora and the media by diverse individuals, associations and agencies concerning the extent of menace of spurious drugs. The reported extent ranged widely between 0.5% (based on the cases analyzed by State regulatory authorities reported in this Report) to 35% (ascribed to WHO Studies). However, WHO itself has written in response to a query from the Indian Government that ‘There is no actual study by WHO, which concludes
that 35% of World’s spurious drugs are produced in India’. Some estimation
of the quantum of spurious drugs in the market quoted is available based on the cases detected in selected pockets and regions in the country. Validation of the claims made by several agencies was not available as concrete and authenticated evidence even at the time of the submission of this final report.

15. The Committee has concluded that it is absolutely essential to evaluate systematically and scientifically the extent of the problem. For this purpose, several approaches including the model proposed by the Delhi Pharmaceutical Trust were considered by the Committee. It is recommended that a scientifically and statistically valid methodology should be used to evaluate and quantify the extent of the problem of spurious drugs at various levels in the supply chain at the Regional and National levels. The Committee, in its interim report had recommended that the Government should provide funds for this study. The Government has since agreed to provide adequate funds for undertaking the study.

16. The Committee has come to the conclusion that while the present Drugs And Cosmetics Act contains various provisions for effective punitive action against manufacturers and distributors of spurious drugs, more deterrent measures were needed. Although in the overall context of legal system, the offences having penalty of more than 3 years are construed to be cognizable, there is a need to make a distinct provision in the Drugs and Cosmetics Act itself declaring all offences related to spurious drugs as cognizable and non-bailable. Apart from penalties of stiff fines and imprisonment for life, specifically in those cases, which had resulted in grievous body harm or loss of life, death penalty was required to be provided.

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 authorizing them to file prosecutions for spurious drug offences under the Drugs & Cosmetics Acts. It may be necessary to invoke changes in the related statutory provisions including fresh legislations for effective implementation of the steps needed to be taken for both punitive and deterrent punishments 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.

21. Specific recommendations for amending the provisions of existing Drugs & Cosmetics Act 1940 to give effect to the recommendations in 14-19 above have been made by the Committee. The details can be seen in Annexure-13 of the Report.

22. The Committee is of the view that the responsibility for effective management of the issue of spurious drugs, their manufacture and distribution lies not only with the Drug Regulatory Agencies at the Centre and in the States and the Police, but also with all the other stake holders, namely, the medical and para-medical professionals, pharmaceutical companies, distributors and retail trade, patients, the media, the NGOs and
the public at large. This is largely because these components of the healthcare system are the most affected and in many cases are the first contacts in the supply chain.

23. The Committee feels that, while, many of the stake holders, such as the
regulatory agencies and the pharmaceutical companies have sufficient expertise to detect and analyse spurious drugs, others need to be made aware of the problems involved, the potential grievous harm which can be caused and the initiatives they could and should take in tackling this menace. The Committee suggests that the industry and trade associations should play a more active and collaborative role as has recently been done by Indian Pharmaceutical Alliance (IPA) to arrest the menace of spurious drugs in the country. Specific recommendations concerning the way ahead have been made in the Interim Report.

24. The report of the Committee has been divided in part A and part B according to the terms of reference of the Committee. Part A deals comprehensively with the issue of implementation of all the rules and regulations, which guide, monitor and control the activities of the providers of the healthcare system in the country and the way to bring them up to international standards. It provides the design of Central Drug Administration (CDA), its size, functions and the sharing of the responsibilities vis-à-vis the States including directions for licensing of manufacturing units by a central authority. It also deals with the regulatory health food/dietary supplements/therapeutic foods, Indian system of medicines and herbal products, over the counter drugs, medicines & diagnostics. It addresses the issue of drug development and clinical research in India with special reference to the drug regulatory agency including modern biotechnology. Part B covers the problem concerning spurious and substandard drugs in the country and the measures to deal with it.

 

ANNEXURE III

RECOMMENDATIONS FROM THE TANDON COMMITTEE REPORT
6.1 During the Working Group’s interaction with a number of representatives of the Pharmaceutical Industry, it became evident that most of them were not even aware of the variety of science and technology measures that can be used, or are in use elsewhere, to protect their products from being substituted by spurious, sub-standard or counterfeit alternatives.
6.2     Furthermore, currently, only a very limited use is being made of any of these technologies, except probably “holograms”/ bar codes. Yet, already some of these technologies are available indigenously.
6.3     A survey of the global scenario – the European Commission, the United States Food and Drug Administration (USFDA) and the World Health Organization (WHO) – reveals that, as of today, there is no technology applicable world-wide.  Hence, the Working Group has tried to collate the various technologies which could be utilized, fully recognizing their advantages and disadvantages / weaknesses. The Working Group has no personal choice in this respect.
6.4     Whatever technology is used, it is imperative that, simultaneously, a consumer awareness programme – be it for an individual, an institution, the retail chemist or a bulk user – would have to be instituted for its successful utilization. Modern Information Technology could be used for this purpose.
6.5     In addition to the scientific and technological measures, it must be emphasized that there is a need to strengthen the existing monitoring mechanisms and upgrade and modernize the drug testing laboratories. The latter should be provided state-of-the-art technologies to sensitively and speedily test the samples sent to them for analysis.  This would require equipment like mass spectrometers, etc.
6.6     Similarly, it because obvious to the Working Group that there is a need to create a centralized “Data base” of all drugs and drug manufacturing units in the country which could help trace the origin of a drug (e-pedigree) through the full supply chain. Simultaneously, there is a need to streamline the law enforcement system (as already proposed by the Parliament of India recently)   
RECOMMENDATIONS ON SUB STANDARD DIAGONISTIC CENTRES
7.1     The Working Group, aware of the already existing programme for accreditation of diagnostic centres, did not deliberate, in detail, on this subject.  However, some important observations and recommendations are summarized in the following paragraphs.
7.2     Observations
7.2.1  No licensing, not even registration, is required in most parts of India for the opening of a diagnostic centre.
7.2.2  Even in those states (5 in number), where registration is required to be done, it is only a one time affair, i.e. any centre, once registered, does not require any renewal of its registration throughout its existence. In other words, any person, howsoever unqualified, can open a diagnostic centre in most parts of India, overnight.  This, however, does not mean that there is a dearth of qualified pathologists in the country.  In fact, India is blessed with several top-notch pathologists.
7.2.3  There are also some advantages and disadvantages of a diagnostic centre that is attached to a hospital vis-à-vis one that operates on a stand-alone mode.  The advantage of the former is that the pathologists can easily interact with the clinicians to make better sense, and have a better understanding, of the results of the diagnostic tests performed on the patients while the advantage of the latter is that costly and state-of-the-art diagnostic equipment is more easily available there for use by multiple consumer groups.
7.2.4  The guidelines issued by the National Accreditation Board for Testing and Calibration Laboratories (NABL), Government of India, for the accreditation of diagnostic centres are excellent.  However, accreditation by the NABL is not mandatory and the diagnostic centres are welcome to get themselves accredited by the NABL as per their own will and wish.
7.2.5  Often, even the most reputed of diagnostic centres are found to be, wittingly or un-wittingly, declaring that all their laboratories across the country are accredited by the NABL, while the fact may be that only 1 or 2 of their laboratories, out of several across the country, may have been granted NABL accreditation.  Accreditation by the NABL of any given lab of any given diagnostic centre does not imply accreditation of all other laboratories of that centre across India.  In other words, each and every laboratory has to be individually accredited by the NABL for any centre to claim that it has NABL accreditation for all its diagnostic services. 
7.3     Recommendations
7.3.1  Just like blood banks, all diagnostic centres in India should be mandatorily registered for a fixed period of time before the start of operations.  This registration should be renewed after the lapse of the fixed period of time, say a few years, and only after a reassessment of the centres’ capabilities, by way of availability of qualified professionals and equipments, should the registration be renewed by the designated authority in the Government.
7.3.2  Their functioning should be regulated, just like that of the blood banks, by the Government.
7.3.3  The NABL is a very good example of an accreditation system; accreditation by the NABL should, therefore, be made mandatory for all diagnostic centres across India.  However, to enable this to happen, the NABL should be strengthened by way of staff / manpower