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.

We wrote a piece for ibnlive.com on the major differences between the government’s Lok Pal Bill, 2011 and the Jan Lok Pal Bill drafted by Anna Hazare’s group.  The note is reproduced below.   The streets are witnessing a demand that the government’s Lok Pal Bill be replaced by the Jan Lok Pal Bill (JLP) as drafted by the team led by Anna Hazare.  There are several significant differences between the two bills.  In this note, we describe the some of these differences. (See here for more on the Lok Pal Bill).   First, there is a divergence on the jurisdiction of the Lok Pal.  Both bills include ministers, MPs for any action outside Parliament, and Group A officers (and equivalent) of the government.  The government bill includes the prime minister after he demits office whereas the JLP includes a sitting prime minister.  The JLP includes any act of an MP in respect of a speech or vote in Parliament (which is now protected by Article 105 of the Constitution).  The JLP includes judges; the government bill excludes them.  The JLP includes all government officials, while the government bill does not include junior (below Group A) officials.  The government bill also includes officers of NGOs who receive government funds or any funds from the public; JLP does not cover NGOs.   Second, the two Bills differ on the composition.  The government bill has a chairperson and upto 8 members; at least half the members must have a judicial background.  The JLP has a chairperson and 10 members, of which 4 have a judicial background.   Third, the process of selecting the Lok Pal members is different.  The JLP has a two stage process.  A search committee will shortlist potential candidates.  The search committee will have 10 members; five of these would have retired as Chief Justice of India, Chief Election Commissioner or Comptroller and Auditor General; they will select the other five from civil society.   The Lok Pal chairperson and members will be selected from this shortlist by a selection committee.  The selection committee consists of the prime minister, the leader of opposition in Lok Sabha, two supreme court judges, two high court chief justices, the chief election commissioner, the comptroller and auditor general, and all previous Lok Pal chairpersons.   The government bill has a simpler process.  The selection will be made by a committee consisting of the prime minister, the leaders of opposition in both Houses of Parliament, a supreme court judge, a high court chief justice, an eminent jurist, and an eminent person in public life.  The selection committee may, at its discretion, appoint a search committee to shortlist candidates.   Fourth, there are some differences in the qualifications of a member of the Lok Pal.  The JLP requires a judicial member to have held judicial office for 10 years or been a high court or supreme court advocate for 15 years.  The government bill requires the judicial member to be a supreme court judge or a high court chief justice.  For other members, the government bill requires at least 25 years experience in anti-corruption policy, public administration, vigilance or finance.  The JLP has a lower age limit of 45 years, and disqualifies anyone who has been in government service in the previous two years.   Fifth, the process for removal of Lok Pal members is different.  The government bill permits the president to make a reference to the Supreme Court for an inquiry, followed by removal if the member is found to be biased or corrupt.  The reference may be made by the president (a) on his own, (a) on a petition signed by 100 MPs, or (c) on a petition by a citizen if the President is then satisfied that it should be referred.  The President may also remove any member for insolvency, infirmity of mind or body, or engaging in paid employment.   The JLP has a different process. The process starts with a complaint by any person to the Supreme Court.  If the court finds misbehaviour, infirmity of mind or body, insolvency or paid employment, it may recommend his removal to the President.   Sixth, the offences covered by the Bills vary.  The government bill deals only with offences under the Prevention of Corruption Act.  The JLP, in addition, includes offences by public servants under the Indian Penal Code, victimization of whistleblowers and repeated violation of citizen’s charter.   Seventh, the government bill provides for an investigation wing under the Lok Pal.  The JLP states that the CBI will be under the Lok Pal while investigating corruption cases.   Eighth, the government bill provides for a prosecution wing of the Lok Pal.  In the JLP, the CBI’s prosecution wing will conduct this function.   Ninth, the process for prosecution is different.  In the government bill, the Lok Pal may initiate prosecution in a special court.  A copy of the report is to be sent to the competent authority.  No prior sanction is required.  In the JLP, prosecution of the prime minister, ministers, MPs and judges of supreme court and high courts may be initiated only with the permission of a 7-judge bench of the Lok Pal.   Tenth, the JLP deals with grievance redressal of citizens, in addition to the process for prosecuting corruption cases.  It requires every public authority to publish citizen’s charters listing its commitments to citizens.  The government bill does not deal with grievance redressal.   Given the widespread media coverage and public discussions, it is important that citizens understand the differences and nuances.  This may be a good opportunity to enact a law which includes the better provisions of each of these two bills.