Lapses in the process of drug approval in India

Sakshi - May 29, 2012

The Parliamentary Standing Committee on Health and Family Welfare tabled a Report in Parliament on May 8, 2012, on the functioning of the Central Drugs Standard Control Organization (CDSCO). CDSCO is the agency mandated with the regulation of drugs and cosmetics in India. The Report covers various aspects of drug regulation including organizational structure and strength of CDSCO, approval of new drugs, and banning of drugs, among others. Following the Report, the Minister of Health and Family Welfare has constituted a Committee to look into the procedure for drug regulation. The Committee is expected to make its submissions within a period of two months. This post focuses on irregularities in the approval of new drugs by CDSCO. It discusses the regulations relating to drug approval and the Standing Committee's observations on the working of CDSCO. Approval of new drugs Drugs are regulated by the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetic Rules, 1945 [Rules]. The CDSCO, under the Ministry of Health and Family Welfare, is the authority that approves new drugs for manufacture and import. State Drug Authorities are the licensing authorities for marketing drugs. New Drugs are defined as:

drugs that have not been used in the country before,
drugs that have been approved by a Licensing Authority but are now being marketed for different purposes, and
fixed dose combinations of two or more drugs that have been individually approved before but are proposed to be combined in a fixed ratio that has not been approved.

The Rules require an applicant for a new drug to conduct clinical trials in India to determine the drug’s safety and efficacy. These trials are necessary for both domestically manufactured and imported drugs. However, the authority can exempt a drug from the requirement of local and clinical trials in the public interest based on data available in other countries. Observations and recommendations of the Committee The Committee found that a total of 31 new drugs were approved between January 2008 and October 2010 without conducting clinical trials on Indian patients. The Report mentioned that drug manufacturers, CDSCO officials and medical experts colluded to approve drugs in violation of laws. Following are some of the Report’s findings:

Under the Rules, the Drugs Controller General (India) (DCGI), the head of CDSCO, can clear sites of clinical trials after ensuring that major ethnic groups are enrolled in these trials to have a truly representative sample. This rule was violated by the DCGI when sites for clinical trials were approved without ensuring diversity. The Committee recommended that the DCGI approve sites for trials only if they cover patients from major ethnic backgrounds.

The Report found that certain actions by experts were in violation of the Code of Ethics of the Medical Council of India. A review of expert opinions revealed that several medical expert recommendations had been given as personal opinions rather than on the basis of scientific data. Additionally, many expert opinions were written by what the Report calls ‘the invisible hands’ of drug manufacturers. The Committee recommended that CDSCO formulate a clear set of written guidelines on the selection process of experts with emphasis on expertise in the area of drugs.

The Rules ban the import and marketing of any drug whose use is prohibited in the country of origin. CDSCO violated this rule by approving certain Fixed Dose Combination drugs for clinical trials without considering the drugs’ regulatory status in their respective country of origin. Drugs such as Deanxit and Buclizine, which have been prohibited for sale and use in their countries of origin, Denmark and Belgium, respectively, were approved for clinical trials. The Committee recommended an inquiry into the unlawful approval of these drugs.

The Rules require animal studies to be conducted for approval of a drug for use by women of reproductive age. CDSCO violated this rule in approving Letrozole for treating female infertility. Globally the drug has only been used as an anti-cancer drug for use among post-menopausal women. The drug has not been permitted for use among women of reproductive age because of side effects. The Committee recommended that responsibility be fixed for unlawfully approving Letrozole.

Rules require Post-marketing Safety Update Reports (PSURs) on drugs to be submitted to CDSCO. PSURs are used to collect information on adverse effects of drugs on Indian patients as a result of ethnic differences. When asked by the Committee to furnish PSURs on 42 randomly selected new drugs, the Ministry was able to submit PSURs for only 8 drugs. The Report contended that this action reflected a poor follow-up of side effects on Indian patients. The Committee recommended that manufacturers of new drugs be warned about suspension of marketing approval unless they comply with mandatory rules on PSURs.

Parliament

The Tribunals Reforms Bill, 2021, in the context of the recent Supreme Court judgement

Aditya Kumar - August 2, 2021

The Tribunals Reforms Bill, 2021 was introduced in Lok Sabha today. It seeks to dissolve certain existing appellate bodies and transfer their functions (such as adjudication of appeals) to existing judicial bodies (mainly high courts) (see Table 1). It also amends the Finance Act, 2017, to bring certain provisions (such as qualifications, appointments, term of office, salaries and allowances of tribunal members) under the purview of the Bill. Currently, these provisions are notified through Rules under the Finance Act, 2017.

Note that the 2017 Act reorganised the Indian tribunal system to ensure uniformity in their administration by amalgamating certain tribunals based on the similarity in their functional domain. It also delegated powers to the central government to make Rules to provide for the qualifications, appointments, term of office, salaries and allowances, removal, and other conditions of service for chairpersons and members of these tribunals.

This Bill replaces an Ordinance with similar provisions that was promulgated in April 2021. The 2021 Ordinance was challenged in the Supreme Court over its compliance with past Supreme Court judgements. In July 2021, the Court struck down certain provisions of the Ordinance, such as the four-year term of office for members, and the minimum age bar of 50 years to be appointed as a member of a tribunal. Table 2 shows a detailed comparison of key provisions of the 2021 Bill with the 2021 Ordinance and the principles laid down by the Supreme Court in its judgement. The Bill does not conform to the judgement of the Supreme Court and retains the provisions of the Ordinance that were struck down by the Court.

For an analysis of the 2021 Ordinance, please see our note here. For more details on the evolution of the tribunal system in India, please see our note.

Table 1: Transfer of functions of key appellate bodies as proposed under the Bill

Appellate body	Role	Proposed entity
Appellate Tribunal under the Cinematograph Act, 1952	Adjudication of appeals against the Board of Film Certification	High Court
Appellate Board under the Trade Marks Act, 1999	Adjudication of appeals against orders of the Registrar	High Court
Appellate Board under the Copyright Act, 1957	Adjudication of certain disputes and appeals against orders of the Registrar of Copyright. Disputes include those related to publications and term of the copyright	Commercial Court or the Commercial Division of a High Court*
Authority for Advance Rulings under the Customs Act, 1962	Adjudication of appeals against orders of the Customs Authority for advance rulings	High Court
Appellate Board under The Patents Act, 1970	Adjudication of appeals against decisions of the Controller on certain matters. Matters include applications for patents and restoration of patents.	High Court
Airport Appellate Tribunal under the Airports Authority of India Act, 1994	Adjudication of: disputes arising from the disposal of properties left on airport premises by unauthorised occupants, and for appeals against the order of an eviction officer	Central government, for disputes arising from the disposal of properties left on airport premises by unauthorised occupants. High Court, for appeals against orders of an eviction officer.
Airport Appellate Tribunal under the Control of National Highways (Land and Traffic) Act, 2002	Adjudication of appeals against orders of the Highway Administration on matters including, grant of lease or licence of highway land, removal of unauthorised occupation, and prevention of damage to highway.	Civil Court^#
Appellate Tribunal under the Protection of Plant Varieties and Farmers' Rights Act, 2001	Adjudication of appeals against certain orders of Registrar or Plant Varieties and Farmer Rights Authority	High Court
Appellate Board under the Geographical Indications of Goods (Registration and Protection) Act, 1999	Adjudication of appeals against orders of the Registrar	High Court

Notes: * Constituted under the Commercial Courts Act, 2015; # Refers to a Civil Court of original jurisdiction in a district and includes the High Court in the exercise of its ordinary original civil jurisdiction.
Sources: The Tribunals Reforms Bill, 2021; Parent Acts of the appellate bodies; PRS.

Table 2: Key provisions in the 2021 Bill and the Ordinance vis-a-vis the Supreme Court judgements

Provisions	2021 Ordinance	Supreme Court Judgement of July 2021	2021 Bill
Term of office of Chairperson and members	Four-year term with eligibility for re-appointment.	The Court stated that a short tenure of members (such as three years) along with provisions of re-appointment increases the influence and control of the Executive over the judiciary. In a short tenure, by the time the members achieve the required knowledge, expertise and efficiency, one term gets over. This prevents enhancement of adjudicatory experience, thereby, impacting the efficacy of tribunals. The Court struck down the provision of four -year term and reiterated its past judgements, which recommended a five-year term with eligibility for re-appointment.	Same as that in Ordinance.
Minimum age requirement for appointment of Chairperson and members	50 years	The Court observed that the minimum age requirement of 50 years violates past Court judgements, where the Court has stated that advocates with at least 10 years of relevant experience must be eligible to be appointed as judicial members, as that is the qualification required for a High Court judge. Such a high age limit also prevents the recruitment of young talent. The provision was struck down.	Same as that in Ordinance.
Time limit for appointments	Preferably within three months from the date of the recommendations of the search-cum-selection committee.	The Court noted that not mandating the central government to make appointments within three months (from the date of recommendation of the search-cum-selection committee) leads to delay in the appointment of members. This impacts the functioning and efficacy of tribunals. The provision was struck down over non-compliance with past judgements, which mandated the appointments to be made within three months.	Same as that in Ordinance.
Number of recommendations for a post	Two names for each post.	The Court stated that the recommendations for appointment of members by the search-cum-selection committee should be final. The Executive must not be allowed to exercise any discretion in matter of appointments in a tribunal. The Court struck down the provision and reiterated its past judgement, which specified that the selection committee must suggest one name for each post. The Committee may recommend one name in wait list.	Same as that in Ordinance.

Sources: The Tribunals Reforms Ordinance, 2021; The Tribunals Reforms Bill, 2021; Madras Bar Association vs Union of India, W.P.(C) No. 000502 of 2021; PRS.

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Lapses in the process of drug approval in India

The Tribunals Reforms Bill, 2021, in the context of the recent Supreme Court judgement

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