Clinical trials in India:rising outsourcing of clinical trials to India, with concerns about little benefit or relevance to the public health needs of the country

Clinical trials in India continue to be in the news, unfortunately a fair bit being negative coverage. Over the last few years, there has been continuing outrage on the issue of rising outsourcing of clinical trials to India, with concerns about little benefit or relevance to the public health needs of the country. While this dust has not even settled, allegations of unethical conduct in clinical trials have again brought a focus on the need for regulatory reform and stringent ethical safeguards.

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THE CONTROVERSY ON TRIALS IN INDORE

The recent reporting of controversial drug trials being conducted by doctors of the government medical college and private practitioners on ‘mentally challenged’ patients in Indore has caused uproar. It was alleged that for more than two years, from 2008 to 2010, trials were conducted flouting ethics guidelines. The Madhya Pradesh government levied a fine of Rs 5000 each on the doctors involved, and this was seen widely as being paltry and insufficient punishment. As details emerged, questions were raised about the role of independent or commercial (as compared to institutional) ethics committees, improper documentation of consent, vulnerability of research participants as well as the thorny issue of private practice (and in this case, research in private clinics) by government doctors.

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GROWTH OF THE CLINICAL TRIAL INDUSTRY IN INDIA AND ETHICS VIOLATIONS: IS REGULATORY REFORM ENOUGH

Research being conducted by pharmaceutical and biotechnology companies in India has been on the increase. Added to this, has been the mounting quantum of outsourced research facilitated by Contract Research Organizations (CROs) with the promise of cheaper and faster conduct of trials as compared to the west. From 40 to 50 trials in 2003, the country saw around 1850 trials registered with the government registry in June 2011. Mushrooming clinical research courses, often unregulated, have sprung up with an aim of servicing the need of personnel for conducting clinical research.

While the escalating research quantum has, to some extent, served to benefit the Indian population which now is undergoing a demographic transition with both infectious and non-communicable diseases being commonplace, it has also raised concerns that ethical conduct is often forgone when the primary interest increasingly is profit generation. The specter of unethical trials being frequently reported is a reflection of an ailing and substantially ineffective research regulation system in India. While biomedical research in the country has increased exponentially in the last decade, reforms in regulations have only occurred at snail's pace. Intent has been demonstrated towards such reform, but needs to be substantiated with priority policy changes. Regulatory progress is only one element of the solution—other steps are also needed to move forward in this area.

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WHAT NEEDS TO BE DONE?

It's quite clear that there is a need for reform. Improvement has already been seen in certain areas, such as the stress on clinical trial registration in India through the medium of the Clinical Trial Registry -India (as well as Indian journals insisting on such registration for accepting resultant manuscripts). The increasing awareness about ethical requirements in research, as well as the role of activists in questioning trial conduct when deemed exploitative, has also resulted in a positive change to some extent. However, a lot still needs to be done. This requires a multi-faceted approach and involvement of all the stakeholders with an aim for more robust science, which incorporates a strong commitment to ethics.

Stringent regulations and laws

The role of stronger legal oversight, in light of the guidelines not serving to be enough in curbing deviant research conduct, cannot be emphasized enough. Advocacy is needed, so that the draft bill on Biomedical Research on Human Participants (Promotion and Regulation) prepared by the Indian Council of Medical Research is put in the public domain for discussion and refinement, and is then tabled in the parliament on a priority basis. Such a law can provide mechanisms for legal remedy in the case of questionable and/or exploitative research.

The number of Ethics Committees (ECs) in the country is rising, but there is no clear estimation of the total numbers. The quality of conduct of ECs is often quite variable, and also there is no standardized training or orientation for members. Unless there is mandatory registration of ethics committees and an accreditationprocess, it would be difficult to ensure that ECs are optimally focusing on their core duty of protection of research participants. In a positive development, some ECs in India have voluntarily undergone accreditation through the Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP), and the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRP). Indian EC members who were surveyed in the past, also felt that there is a need for formal training of EC members in ethics, and networking of ECs. The Forum for Ethics Review Committees in India (FERCI), which recently conducted its first national conference, could serve as a platform to respond to these needs. E-groups and online discussion forums have also helped in providing avenues for sharing of experiences and updates. ECs also need to proactively engage researchers and conduct on-site monitoring of projects; this can help in identifying and addressing transgressions.

The role of mentorship is crucial in training research investigators. If the mentors demonstrate and require that trainees conduct research of a high standard, it can help a great deal in producing researchers for the future, who do not cut corners and believe strongly in scientific integrity.

Transparency is one of the core guiding principles in the ICMR Ethics Guidelines. Institutions and investigators need to put more information into the public domain: About the kind of research they are carrying out, the rationale for choosing a certain set of participants and the interventions, the standard of care in the research, ancillary care and post-trial obligations etc. While it might not be possible to always disclose proprietary information related to the intervention or some elements about the research, the relevant ethics committee should at least insist on full information being provided. Another area where enough attention is not often paid is the EC demanding to see the budget of the study, the details of any MoUs signed with the sponsors, as well as details of other sites (in a multi-site study).

Global attention is now being paid to the need for public engagement in science. There is a need to enhance the public understanding for research, and to develop a civic dialogue around what kind of research is necessary. This will help in creating widespread support for scientific endeavors. Mechanisms of communication being present between research participants and the communities they belong to, and between the researchers and ECs will help avoid misunderstandings developing due to a trust deficit. Scientists should also use the media at local and national levels to explain the rationale for the research which is being conducted, and how it relates to the health priorities in that context.

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CONCLUSION

India, as an emerging economy needs to continue to promote a strong culture of research and development, including in the health sector. However, attention needs to be paid to ensuring that stringent quality checks are built in, and that investigators conduct research in an impeccable manner. Failure to do so will dent the credibility of the research enterprise, affecting not just investigators or institutions conducting research, but also those planning to do so.

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Footnotes

Source of Support: Nil

Conflict of Interest: None declared.

An Overview of Regulatory Process for Pharmaceutical Sector in India.

India is about one-third the size of the USA in terms of area. India is a pool of diverse population base of more than 1.2 billion and is a home for a numerous diseases, Institutions and hub of contract manufacturers and researchers. Indian economy stand as the third largest based on the Purchasing Power Parity (PPP) and in terms of globally eleventh largest by nominal Gross Domestic Product (GDP). India is today one of the top emerging markets in the global pharmaceutical scene. The sector is highly knowledge based and its steady growth is positively affecting the Indian economy. The organised nature of the Indian pharmaceutical industry is attracting several companies that are finding it viable to increase their operations in the country. Further, India is home to about 10,500 manufacturing units and over 3,000 pharma companies. India exports all forms of pharmaceuticals from APIs to formulations, both in modern medicine and traditional Indian medicines. This article provides a perspective on the Indian pharmaceuticals regulatory process from pre-independence era to till date.

Key words

CDSCO, Ministry of Health, DCGI, Subject Expert Committee, Regulatory process.

Introduction

Geographically, India is comprise area of 3.29 million sq. km. (1.27 million sq. mi.); about one-third the size of the USA. Genetically, culturally and socio-economicallydiverse population base of more than 1.2 billion is a home for a numerous diseases as well as for qualified, English-speaking professionals, Institutions and hub of contract manufacturers and researchers [1,2,3].

Today, Indian economy stand as the third largest based on the Purchasing Power Parity (PPP) and in terms of globally eleventh largest by nominal Gross Domestic Product (GDP), due to its rapid growth, especially over the last decade, India is considered an industrialised nation. Apart from being a multi-ethnic, pluralistic society, India is also blessed with a variety of wildlife.

Indian Pharmaceutical Industry

McKinsey & Company a global management and consulting firm, through a major study it has reported that by 2020 India’s pharmaceutical sector will touch US$ 45 billion. The reasons for this optimism are well founded. In the period 2002–2012, the country’s healthcare sector grew three times in size, touching US$ 70 billion from US$ 23 billion. India's pharmaceutical market experienced a similar boom, reaching US$ 18 billion in 2012 from US$ 6 billion in 2005. The report further states that the Indian pharmaceutical market will be the sixth largest in the world by 2020.

The rise of pharmaceutical outsourcing and investments by multinational companies (MNCs), allied with the country's growing economy, committed health insurance segment and improved healthcare facilities, is expected to drive the market’s growth. India is today one of the top emerging markets in the global pharmaceutical scene. The sector is highly knowledge based and its steady growth is positively affecting the Indian economy. The organised nature of the Indian pharmaceutical industry is attracting several companies that are finding it viable to increase their operations in the country.

Further, India is home to about 10,500 manufacturing units and over 3,000 pharma companies. India exports all forms of pharmaceuticals from APIs to formulations, both in modern medicine and traditional Indian medicines [4].

The Regulatory Process of India

The growth of pharmaceutical market in India has been very eye-popping during the last two decades.The growth of pharmaceutical market depends upon the various factors among one is drug regulatory system and regulatory legislations. Current scenario of drug regulatory system in India is on the way of continuous improvement and under transition phase viz., Strengthening of Central licensing agency, introduction of gazette notifications and amendment, formation of committees (SEC/NDAC, expert, technical and apex).

The history of drug regulatory dates back from British era, which time pharmaceuticals wereimported from abroad. Following the World War I, this situation has changed, and notonly were pharmaceutical products importedin increasing volume, but the demand forindigenouslydeveloped products also grew. However,many unprincipled foreign manufacturers flooded the Indian market with spurious and adulterated drugs andthis led to a rapid expansion ofpharmaceutical production during the earlypart of the century, and it became clear thatcomprehensive legislation was need of the hour. Hence, Government, then, formed a Drug inquiry committee under Sir Ram Nath Chopra also known as ‘Chopra Committee’ whose recommendations later on tabled amidst growing protest in legislative assembly as ‘The Drug Bill’ later on amended to the Drugs and Cosmetic Act 1940 (D and C Act) and Drugs and Cosmetic rules of 1945 [5]. This would be the central legislation that regulates India's drug and cosmetic import, manufacture, distribution and sale. This also established the Central Drugs Standard Control Organization (CDSCO) [6]. The CDSCO works in the Directorate General of Health services, is a division in Ministry of Health and Family welfare, Government of India, headed by Drug Controller General of India (DCGI). At present CDSCO has six zonal offices, four sub-zonal offices, 11 port offices and sixlaboratories under its control. It has four zonal, three sub-zonal and seven port/airport offices and six laboratories to carry out its activities [7].

Figure 1: Represents the current process and involvement of ministries and r.egulatory authorities.

The various committees formed to facilitate the regulatory process and decision making of DCGI, a statutory board and a committee have been framed called Drugs Technical Advisory Board (DTAB) and Drug Consultative Committee (DCC) separately for Modern Scientific System of Medicine and Indian traditional system of Medicine and a provision of Central Drug Laboratory at Central Research Institute, Kasauli (HP) for testing of drugs. DTAB comprises of technical experts who advises central and state governments on technical matters of Drug regulation. Amendment, if any, to Drug and Cosmetic are made after consulting this board. Drug Consultative Committee, which has central and state Drug Control officials as its members, ensures drug control measures in all over India. It is an advisory body for the Central Government, the State Government and DTAB [8-16].

Table 1: Different committees set up by MoH & FW

The Indian government, realizing the potential of clinical research for new therapies, has modified and amended Schedule Y to the Drug and Cosmetics Rules of 1945. Schedule Y [17] establishes a set of guidelines and requirements for clinical trials. However, Schedule Y was written with the generics industry in mind but increase entry of foreign pharmaceutical companies after the introduction of strict patent rules in the area of clinical research led the government to introduce many changes. The government recognized the importance of their regulation and thus developed Ethical and Regulatory Guidelines. The Indian Council of Medical Research (ICMR) issued the Ethical Guidelines for Biomedical Research on Human Subjects in 2000 [18] and CDSCO released Indian Good Clinical Practice (GCP) guidelines in 2001 [19].

Without a regulatory requirement for GCP compliance, however, most companies did not invest in clinical trials. Low quality data resulted in worsening India's reputation. Also, India's strict bureaucratic system made it hard to manage simple tasks like getting customs clearance for the equipment's. There were regulations which resulted in a phase lag, allowing companies to conduct a Phase II trial in India only if a Phase III study was going on somewhere else [20]. However in 2005, CDSCO has come up with drastic revisions to Schedule Y to try to bring it on at par with internationally accepted definitions and procedures. The changes which took place were

1. Definitions for Phase I-IV trials, which eliminated the Phase lag [21].

2. Clear responsibilities for investigators; and sponsors.

3. Requirements for notifying changes in protocol.

The Indian Government gave another boost to the drug-development industry by canceling the 12 percent service tax on clinical trials in 2007 [22]. However, on Union budget presented 12 Jul 2014 chose to withdraw the service tax exemption provided on technical testing of new drugs, including vaccines and herbal remedies [23]. In February 2009, the industry applauded new regulations on exporting samples. Previously, an export license was needed to get samples out of India but it has been removed now saving the time.

In order to further strengthen the scientific review and approval of new drugs/devices, the ministry has appointed 12 New Drug Advisory Committee’s (NDAC) and 7 Medical Device Advisory Committee’s (MDAC) to advise the CDSCO in making their decisions on approval of new drugs and global clinical trials, the NDAC expert committees have started reviewing the global clinical trial documents, from mid 2011 [24].

As per the supreme court's directives, the Ministry of Health and Family Welfare (MoHFW) has off late come up with strong confidence building measures to protect the rights of the subjects participating in clinical trials (CTs), by notifying three back to back amendments to drugs and cosmetic rules namely Rule 122 DAB (first amendment) [25], Rule 122 DAC (second amendment) [26] and Rule 122 DD (third amendment) [27]. Though these steps have been in the right direction, at the same time these have raised challenges for the pharma/device/biotech industry/Contract Research Organizations (CROs)/academic investigators and regulators themselves, all of whom have had to realign themselves with the requirements, which are now mandated. Investigators and their teams, the sites ethics committees (ECs) and the site/institutional heads/chairman all have got additional responsibilities as part of their scope. While, ECs have started applying and getting registered themselves. The unregistered ECs cannot legally review and accord their approval for CT protocols. This has led to delays in study initiation at those sites and crippled recruitment projections for approved CTs from the licensing authority (LA). Going forward, it would be advisable for sponsors/CROs to select sites, which are affiliated to registered ECs, rather than risking unregistered sites as part of the study. Approvals being issued for CT protocols have a binding on the applicant to abide with the new rules. This has triggered amendments to informed consent documents and their submission to ECs and LA. Changes in adverse event reporting requirements have forced investigators and ECs apart from the sponsors/CROs to be more vigilant and sensitive to the issue. They need to spend more time on each case than what they used to do in the past and report the event as per the defined process within the stipulated timelines. With time bound actions to be taken for serious adverse events (SAE) leading to CT related injury or death (including issues around compensation), all stakeholders need to have to proper systems in place to ensure compliance. There have been some debatable issues in Rule 122 DAB like provisions of compensation to be provided in case of failure of an investigational product to provide intended therapeutic effect (lack of efficacy); administration of placebo providing no therapeutic benefits or adverse effects due to concomitant medications, which need further clarification. Detailed risk assessment study plans need to be chalked out by sponsors to factor compensation related risks. Probability that people may get lured by economic incentives to participate as subjects in CTs have risen. The sponsors and insurance providers are revisiting the type and level of insurance and indemnity cover needed or which can be provided for the on-going and future CTs. The extent of documentation to be maintained at site, EC, sponsor, CRO and at LA end has grown multi-fold with these rulings.

Rule 122DAB which empowers the DCGI to determine the quantum of compensation that is to be paid to the family of the subject in case of a SAE in clinical trial. This amendment was introduced to allow a case by case review of the facts and circumstances that led to the SAE and accordingly determine the extent of negligence by each of the parties involved. Further to this, the CDSCO has now introduced a system to prescreening of all SAE reports that are to be considered by the DCGI. The prescreening will be done by CDSCO officers based on a prescribed checklist for determining the acceptability of an SAE report in order to ensure that it contains all necessary administrative and technical information necessary for ascertaining the nature and cause of the SAE, thereby allowing prudent determination of the quantum of compensation.

Table 2: DCGI circulars pertaining to the acceptance of Prof. Ranjit Roy Chaudhury Expert Committee recommendations

The expert committees constituted by the MoHFW in Feb 2013 for formulating guidelines, standard operating procedures and approval procedures have been provided recommendations upon receipt of opinion from stakeholders by holding formal meetings in order to come up with an effective policy document. The Recommendations by the six-member Prof. Ranjit Roy Chaudhury Expert Committee as, it suggested setting up of a council to oversee the accreditation of institutions, clinical investigators and institute ethics committees for clinical trials in the country. Stated clinical trials can only be carried out at accredited centers. Both the principal investigator of the trial, and the ethics committee of the institute should be accredited. Only those trials conducted at such centers should be accepted by the Drugs Controller General of India (DCGI).

Seeking to set up a Central Accreditation Council, the panel said the selection of assessors for accreditation and of experts to review new drug applications and other purposes should be made by a random procedure from a Roster of Experts.

Focusing on the importance of informed consent from each participant for clinical trials, the panel said any departure or violation from the approved process should result in blacklisting of the Principal Investigator for at least up to 5 years.

In circumstances where special groups of people who have diminished capacity to protect their interests are involved, the guardian can give consent and this should be witnessed by an independent person who also has to sign the document. Audiovisual recording of the informed consent process should be undertaken and the documentation preserved, adhering to the principles of confidentiality, it said.

Further, in its report states for replacement of the existing 12 drug advisory committees by a single broad expertise-based Technical Review Committee to ensure speedy clearance of applications without compromising on quality of data and rules and regulations.

On compensation for adverse effects (AE) or serious adverse effects (SAE) during trial, the committee puts the onus of responsibility on the sponsor investigator for providing medical treatment and care to the patient at his/their cost till the resolution of the AE/SAE. This is to be given irrespective of whether the patient is in the control group, placebo group, standard drug treatment group or the test drug administered group.

However, it does not favour paying of compensation for injury or death due to totally proven unrelated causes. In all other cases of death or injury/disability, compensation should be paid to the participant or his legal heirs [28].

The MOH & FW has discussed and the recommendations of the expert committee were discussed in a meeting with its members. During the meeting, clarifications on certain recommendations were obtained from the committee. After the meeting, the ministry in-principle accepted the recommendations of the committee [29].

The Drugs and Cosmetics (Amendment) Bill, 2013 [30,31]:

• The Drugs and Cosmetics (Amendment) Bill, 2013 was introduced in the Rajya Sabha on August 29, 2013. The Bill amends the Drugs and Cosmetics Act, 1940 and changes the name of the Act to the Drugs, Cosmetics and Medical Devices Act, 1940.

• The Bill proposes changes in the regulation of the import, export, manufacture, distribution and sale of drugs, cosmetics and medical devices and to ensure safety, efficacy, quality and conduct of clinical trials.

• The definition of drugs is changed to include new drugs that are (i) not in significant use in India and are not recognised as effective and safe by the Drugs Controller General of India (DCGI);(ii) approved by the DCGI for certain claims but are being marketed with modified/new claims; (iii) a fixed dose combination of two or more drugs, which are individually approved but are being combined for the first time in a fixed/changed ratio; and (iv) all vaccines, Recombinant Deoxyribonucleic Acid derived products, Living Modified Organisms, stem cells, gene therapeutic products etc. which are intended to be used as drugs.

• Under the Act, medical devices were covered under the definition of drugs. The Bill changes this by adding a definition of medical devices to include any instrument, implant, material or other article, including the software, intended to be used specially for human beings or animals for the specific purposes of diagnosis, prevention, treatment or alleviation of any disease or, injury, modification of the body’s anatomy and sustaining life.

• Clinical trials are defined in relation to drugs, cosmetics and medical, and involve their systematic study with the objective of determining their safety, efficacy, performance or tolerance. Anyone initiating a clinical trial has to register with the Central Drug Authority (CDA) and get approval from an Ethics Committee registered with it. The Bill creates provisions for the medical treatment and compensation in case of injury or death of a person during participation in a clinical trial or due to it.

• The Central Government shall establish a CDA to subsume the existing Central Drugs Standards Control Organisation. The CDA will be composed of representatives from the Ministries of Health and Family Welfare, Law, Commerce and Industry, Science and Technology, Chemicals and Fertilisers, DCGI, Indian Council of Medical Research, Directorate General of Health Services, and other experts nominated by the central government, including those from state licensing authorities.

• The CDA shall among others, specify guidelines, structures and requirements for the effective functioning of the central and state licensing authorities; review, suspend or cancel any licence or permission issued by them; and decide on disputes between two or more state licensing authorities relating to the provisions of the Act and rules and regulations made under it.

• The DCGI is the central licensing authority that has the power to issue, renew, suspend or cancel licences for import, export or manufacture of drugs, cosmetics or medical devices or permission for conducting clinical trials. The DCGI also has the sole power to issue licenses for the manufacture, sale, and export of 17 categories of drugs.

• The Bill constitutes the Medical Devices Technical Advisory Board and the Drugs Technical Advisory Board to advise the central and state governments and the CDA on technical matters pertaining to medical devices, and drugs.

In order to ensure standard quality of drugs, cosmetics, and medical devices, the Bill specifies conditions under which they will be considered misbranded, adulterated, and spurious and specifies penalties and offences for the same.

The pending Drugs and Cosmetics (Amendment) Bill, that seeks to centralise the licensing in key categories and establish the central drug authority (CDA), was not tabled for passage in the Parliament during the brief winter session of the House, till date [32].

On 03 Jul 2014, DCGI has issued circulars pertaining to the acceptance of Prof. Ranjit Roy Chaudhury Expert Committee’s following recommendations mentioned in Table 2 [33].

References

1. http://www.rlc.dcccd.edu/ibt/IntroductiontoIndia.pdf
2. http://www.indiaonlinepages.com/population/india-current-population.html
3. http://www.ibef.org/economy/indiasnapshot/facts-about-indian-economy
4. http://www.ibef.org/industry/pharmaceutical-india.aspx
5. Singh H. Sir Ram Nath Chopra: A profile. J Young Pharm. 2009;1:192–4.
6. http://www.cdsco.nic.in/Drugs&CosmeticAct.pdf .
7. http://www.cdsco.nic.in/forms/contentpage1.aspx?lid=1853
8. http://www.medindia.net/indian_health_act/drugs.and.cosmetics.act.1940.the.drugs.consultative.committee.htm .
9. Narrain S. A costly prescription.Frontline. 2005;22:12–25.
10. Damodaran AD. Indian Patent Law in the post – TRIPS Decade: S and T Policy Appraisal. J Intellect Prop Rights. 2008;13:414–23.
11. Tulasi GK, Rao BS.A detailed study of patent system for protection of inventions. Indian J Pharm Sci. 2008;70:547–54.
12. Saha CN, Bhattacharya S. Intellectual property rights: An overview and implications in pharmaceutical industry. J Adv Pharm Technol Res. 2011;2:88–93.
13. Otten A. The GATT TRIPS Agreement and health care in India. Natl Med J India. 1995;8:1–3.
14. Thawani V, Gharpure K, Thawani M. Patent laws must be in the national interest. Indian J Pharmacol. 2006;38:70–2.
15. http://www.Patentmatics.org/pub2005/pub10b.pdf on 13.10.2005 .
16. http://www.Scitech.today.com/story.html?Story_id=31764on 27.03.2005 .
17. http://www.cdsco.nic.in/html/scheduleY%20(Amended%20Version2005)%20original.htm .
18. http://www.icmr.nic.in/ethical_guidelines.pdf .
19. http://cdsco.nic.in/html/GCP1.html .
20. Nundy S, Gulhati CM. A new colonialism – Conducting clinical trials in India. N Engl J Med. 2005;352:1633–6.
21. Thatte UM, Bavdeka SB. Clinical Research in India: Great expectations. J Postgrad Med. 2008;54:318–23.]
22. Ghooi RB. Trials and tribulations of clinical research teaching and training.PerspectClin Res. 2010;1:139–42.
23. http://www.pharmabiz.com/NewsDetails.aspx?aid=83047&sid=1.
24. http://acplgroupindia.co.in/pdf/45.pdf
25. http://www.cdsco.nic.in/forms/list.aspx?lid=1833&Id=31
26. http://www.cdsco.nic.in/forms/list.aspx?lid=1833&Id=31
27. http://www.cdsco.nic.in/forms/list.aspx?lid=1833&Id=31
28. http://www.cdsco.nic.in/forms/SearchMore.aspx?Id=32
29. http://www.cdsco.nic.in/forms/list.aspx?lid=1887&Id=32
30. http://www.drugscontrol.org/Bill%20No.%20LVIII%20of%202013.pdf
31. http://www.prsindia.org/uploads/media/drugs%20and%20Cosmetics /SCR-Drugs%20and%20cosmetics.pdf
32. http://www.pharmabiz.com/NewsDetails.aspx?aid=79557&sid=1
33. http://www.cdsco.nic.in/forms/list.aspx?lid=1843&Id=31

It is high time that some gap-analysis is done in the legislated Acts and Rules to make it apt to the current situation.

It is high time that some gap-analysis is done in the legislated Acts and Rules to make it apt to the current situation. 

Example: Registered Pharmacist certificate is given under Pharmacy Act to accord all privileges in practice of pharmacy. 

Drug license is given under D & C Act to the Reg Pharmacist to SELL / DISTRIBUTE' drugs There is no term like 'CHEMISTS & DRUGGIST' in any Act. 

We find all retail licensed outlets carrying bold board CHEMISTS & DRUGGIST! 

A Reg Pharmacist cannot put up a board 'PHARMACY' unless he compounds and dispenses. 
Actual compounding and dispensing as defined in the Act is obsolete .

All pharmacists except the ones who are actually at the retail counter talks of patient counseling. But neither the Act says so nor the doctors expect the pharmacist to counsel. The patient on his part doesn't know what to expect from the chemist other than the dispensed drugs. 

Legislation doesn't support the pharmacist but is in place to cow-down the pharmacist


Pharmacy profession today have lots of confusions. And this confusion is not at all in favor of pharmacists. Theoretically a pharmacist is an important part in health system but in Indian health policy we do not find even mention of word pharmacist. Pharmacist is believed to be expert in medicines but no one treat him as an expert (whatever may be the reason). It is said that pharmacists practice profession of pharmacy but in actual they do not act or treated as professionals. 

DRUG LEGISLATION IN INDIA

Hello my dear friends & readers,

I am here presenting my next blog on the topic "DRUG LEGISLATION IN INDIA".

Manufacture of modern drugs in India started by the end of 19th century. Initially, Bengal Chemical and Pharmaceutical works at Calcutta, was established by Acharya P. C. Ray in the year 1901 & Alembic Chemical works was established at Baroda by prof. T. K. Gajjar (1).

During 1920-1930 a number of reports of harmful substitutes and adulterants were identified to be marketed in place of genuine drugs.According to Indian Medical gazette there was no control over the manufacturing sale and distribution of drugs in India. As there were no restrictions on quality of drugs that are being imported, unscrupulous manufacturers abroad took advantage and flooded the Indian markets with adulterated & spurious drugs.(2)

As a result of such frauds, the British Government was forced to initiate action for drug legislation. (2). Sir Haroon Zaffer moved a resolution on March 9, 1927 in the council of states recommending to the Governer General "to take immediate steps to control the craze of medicinal drugs by legislation for standardization of preparation and sale of such drugs."(1) In every civilized country the sale of foods and drugs is control by law, but in India there were no such restrictions. To avoid this Lt. Col. H. A. J Gidney in the legislative council demanded for the control of adultarated drugs. On september 4, 1928 he moved for leave to adjourned the house for the consideration of the "Gigantic Quinine fraud". The local press and even the pharmacuetical journal of England supported the agitation.(1)

In response to such agitations, Drugs enquiry committee constituted under the chairman ship of Col. R. N. Chopra as Chairman , Shri C. Govindan nair as secretary and Dr. B. Mukharjee as assistant secretary.(2)The main objectives of this committe were-

* To enquire & check the quality of drugs, that are being imported, manufactured and sold.

* To suggest remedial measures in preventing adulteration.

The committee submitted its report in 1931. Until 1937 British rulers do not act on this report . In 1937 import of drugs bill was introduced with limited reference to import and later it was withdrawn due to public criticism. Finally in the year 1940 The Drugs Bill was introduced in the Parliament, based on the recommendation of D. E. C and after in-depth deliberation The Drugs Act, 1940 was enacted which was latter amended to the Drugs and Cosmetics Act, 1940.(2) Later on, Drugs Enquiry Committee & Health Survey and Development Committee lead foundation for The Pharmacy Act, 1948.(2)

IMPORTANT MILESTONES IN DRUG LEGISLATION OF INDIA-

1857,1878 - Opium act enacted

1919 -- The position Act enacted.

1940 - Drugs Bill introduced in Parliament and Drugs act later amended to Drugs & Cosmetic Act

1946 - Indian Pharmaceutical Codex (I.P.C) published.

1947 - The Indian Nursing Council Act enacted.

1948 -- The Pharmacy Act, 1948 & The Dentists Act, 1948 enacted.

1954 -- The first B. Pharmacy Course approved by Pharmacy Council of India at Birla College, Pilani.

1955 -- First Indian Pharmacopoeia published.

1956 -- Essential Commodities Act enacted.

1960 -- Prevention of Cruelty to Animals Act passed

1962 -- Beginning of National Pharmacy week celebrations in third week of November every year.

1963 -- The Indian Hospitals Phrmacists assosciation (IHPA) was launched at Pilani, Rajasthan.

1970 -- First DPCO (Drugs Price Control Ordrer)

1985 -- The Narcotic Drugs & Psychotropic Substances Act enacted.

1986 -- Consumer Protection Act enacted.

References :

1.Text book of forensic pharmacy by C.k. Kokate and S.B Gokhale.pages 9-13

2. Text book of forensic pharmacy by N.K.Jain.pages 11,13 ,14,16,17

CDSCO is India's main regulatory body for pharmaceuticals and medical devices.it describes laws relating to drugs and cosmetics,notification and adverse drug reactions.it features licence and certification import of drugs and information to the patient.

 It's main functions are * control of quality of imported drugs . * coordinate the activities of states drug control authorities and advice them for uniform action in the country. * lay down regulatory measures and standards of drugs. * grant approval of new drugs proposed to be imported into or to be manufactured in the country. 

Under CDSCO there are many zones and sectors  include:

 *central drugs testing laboratory *regional drugs testing laboratory *Indian pharmacopoeial commission .

references: 1.www.cdsco.nic.in/html/CDSCO%20Contact%2025-9-08.htm 2.www.india-server.com/.../central-drugs-standard-control-35073.html3.www.joeant.com/DIR/info/get/18780/73764 -

It is high time that some gap-analysis is done in the legislated Acts and Rules to make it apt to the current situation. 

Example: Registered Pharmacist certificate is given under Pharmacy Act to accord all privileges in practice of pharmacy. 

Drug license is given under D & C Act to the Reg Pharmacist to SELL / DISTRIBUTE' drugs There is no term like 'CHEMISTS & DRUGGIST' in any Act. 

We find all retail licensed outlets carrying bold board CHEMISTS & DRUGGIST! 

A Reg Pharmacist cannot put up a board 'PHARMACY' unless he compounds and dispenses. Actual compounding and dispensing as defined in the Act is obsolete .

All pharmacists except the ones who are actually at the retail counter talks of patient counseling. But neither the Act says so nor the doctors expect the pharmacist to counsel. The patient on his part doesn't know what to expect from the chemist other than the dispensed drugs. 

Legislation doesn't support the pharmacist but is in place to cow-down the pharmacist