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.

So far, both Houses of Parliament have been witnessing disruptions.  At the beginning of the session, 23 Bills were listed for passage, and 20 were listed for introduction.  Two weeks in, one Bill has been passed by both Houses, and three others by Lok Sabha.  These include Bills dealing with the re-haul of consumer protection laws, regulation of surrogacy, and recognition of transgender persons.  Six Bills have been introduced.  These include three Bills which replace the Ordinances currently in force, and a Bill to regulate dam safety.  In this blog, we discuss the key features of some of these Bills. 

Enhancing rights of consumers

The Consumer Protection Bill, 2018 replaces the Consumer Protection Act, 1986.  It was introduced in view of the significant changes in the consumer market landscape since the 1986 Act.  It introduces several new provisions such as enabling consumers to make product liability claims for an injury or harm caused to them, nullifying unfair contracts which impact consumer interests (such as contracts which charge excessive security deposits), and imposing penalties for false and misleading advertisements on manufacturers, as well as on the endorsers of such advertisements. 

The Bill also sets up Consumer Dispute Redressal Commissions (or courts) at the district, state, and national level, to hear complaints on matters related to deficiencies in services or defects in goods.  While these Commissions are also present under the 1986 Act, the Bill increases their pecuniary jurisdiction: District Commissions will hear complaints with a value of up to one crore rupees; State Commissions between one and ten crore rupees; and National Commission above 10 crore rupees.  The Bill also sets up a regulatory body known as the Central Consumer Protection Authority.  This Authority can take certain actions to protect the rights of consumers as a class such as passing orders to recall defective goods from the market, and imposing penalties for false and misleading advertisements. 

Recognising transgender persons and their rights

Last week, Lok Sabha also passed the Transgender Bill, 2018.  This Bill seeks to recognise transgender persons, confers certain rights and entitlements on them related to education, employment, and health, and carves out welfare measures for their benefit.  The Bill defines a transgender person as one whose gender does not match the gender assigned at birth.  It includes trans-men and trans-women, persons with intersex variations, gender-queers, and includes persons having such socio-cultural identities as kinnar, hijra, aravani, and jogta.  The Bill requires every establishment to designate one person as a complaint officer to act on complaints received under the Bill. 

The Bill provides that a transgender person will have the right to self-perceived gender identity.  Further, it also provides for a screening process to obtain a Certificate of Identity, certifying the person as ‘transgender’.  This implies that a transgender person may be allowed to self-identify as transgender individual, but at the same time they must also undergo the screening process to get certified as a transgender.  Therefore, it is unclear how these two provisions of self-identification and an external screening process will reconcile with each other. 

Regulating surrogacy and overhauling the Medical Council of India

The Surrogacy Bill, 2017 which regulates altruistic surrogacy and prohibits commercial surrogacy was also passed in Lok Sabha.  Surrogacy is a process where an intending couple commissions an eligible woman to carry their child.  In an altruistic surrogacy, the surrogate mother is not given any monetary benefit or reward, and the arrangement only covers her medical expenses and health insurance.  The Bill sets out certain conditions for both the intending couple and the surrogate mother to be eligible for surrogacy.  The intending couple must be Indian citizens, be married for at least five years, and at least one of them must be infertile.  The surrogate mother must be a close relative of the couple, must be married and must have had a child of her own.  Further, a surrogate mother cannot provide her own gametes for surrogacy.

The surrogate mother has been given certain rights with regard to the procedure of surrogacy.  These include requiring her written consent to abort the surrogate child, and allowing her to withdraw from the surrogacy at any time before the embryo is implanted in her womb. 

Another key Bill which was listed for passage in Lok Sabha this session but could not be taken up is the National Medical Commission Bill, 2017 (NMC Bill).  Several amendments to this Bill were introduced in Lok Sabha last week.  The NMC Bill seeks to replace the Medical Council of India, with a National Medical Commission.  It introduces a common final year undergraduate medical examination called the National Exit Test which will also grant the license to practice medicine.  Only medical students graduating from a medical institute which is an institute of national importance will be exempted from qualifying this National Exit Test.  The Bill also gives the NMC the power to frame guidelines to decide the fees of up to 50% of seats in private medical colleges and deemed universities.  The NMC may also grant limited license to certain mid-level practitioners connected with the medical profession to practice medicine.  The qualifying criteria for such mid-level practitioners will be determined through regulations, and they may prescribe specified medicines in primary and preventive healthcare. 

Regulating dam safety

The Dam Safety Bill, 2018 was introduced in Lok Sabha and applies to all specified dams across the country.  These are dams with: (i) height more than 15 metres, or (ii) height between 10 metres to 15 metres and subject to certain additional design and structural conditions.  It seeks to provide for the surveillance, inspection, operation and maintenance of specified dams for prevention of dam failure related disasters.  It creates authorities at the national and state level to formulate policies and regulations on dam safety and implement them.  It also puts certain obligations on dam owners by requiring them to provide a dam safety unit in each dam, among other things. 

When the Bill was being introduced, few opposition members raised objections on the grounds of Parliament’s legislative competence to make a law on dam safety which applies to all states.  They gave the example of the previous Dam Safety Bill, 2010, which applied only to the states of Andhra Pradesh and West Bengal who had adopted resolutions requiring Parliament to pass a law on dam safety.

So far the winter session has seen poor productivity with Lok Sabha working for 14% of its scheduled time, and Rajya Sabha for 5%.  This is one of the least productive sessions of the 16th Lok Sabha.  This is also the last major session before the dissolution of the 16th Lok Sabha.  Both Houses will meet tomorrow after the Christmas break.  With a packed legislative agenda, it is essential for Parliament to function in order to discuss and deliberate the Bills listed.  However, with a limited number of sitting days available in the ongoing session and continued disruptions, it remains to be seen if Parliament will be able to achieve its legislative agenda.

- This post is a modified version of an article published by The Wire on December 26, 2018.