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.

One of the most politically contentious issues in recent times has been the government’s right to acquire land for ‘public purpose’.  Increasingly, farmers are refusing to part with their land without adequate compensation, the most recent example being the agitation in Uttar Pradesh over the acquisition of land for the Yamuna Express Highway. Presently, land acquisition in India is governed by the Land Acquisition Act, an archaic law passed more than a century ago in 1894.  According to the Act, the government has the right to acquire private land without the consent of the land owners if the land is acquired for a “public purpose” project (such as development of towns and village sites, building of schools, hospitals and housing and state run corporations).  The land owners get only the current price value of the land as compensation.  The key provision that has triggered most of the discontent is the one that allows the government to acquire land for private companies if it is for a “public purpose” project.  This has led to conflict over issues of compensation, rehabilitation of displaced people and the type of land that is being acquired. The UPA government introduced the Land Acquisition (Amendment) Bill in conjunction with the Rehabilitation and Resettlement Bill on December 6, 2007 in the Lok Sabha and referred them to the Standing Committee on Rural Development for scrutiny.  The Committee submitted its report on October 21, 2008 but the Bills lapsed at the end of the 14th Lok Sabha.  The government is planning to introduce revised versions of the Bills.  The following paragraphs discuss the lapsed Bills to give some idea of the government’s perspective on the issue while analysing the lacunae in the Bills. The Land Acquisition (Amendment) Bill, 2007 redefined “public purpose” to allow land acquisition only for defence purposes, infrastructure projects, or any project useful to the general public where 70% of the land had already been purchased from willing sellers through the free market.  It prohibited land acquisition for companies unless they had already purchased 70% of the required land.  The Bill also made it mandatory for the government to conduct a social impact assessment if land acquisition resulted in displacement of 400 families in the plains or 200 families in the hills or tribal areas.  The compensation was to be extended to tribals and individuals with tenancy rights under state laws.  The compensation was based on many factors such as market rates, the intended use of the land, and the value of standing crop.  A Land Acquisition Compensation Disputes Settlement Authority was to be established to adjudicate disputes. The Rehabilitation and Resettlement Bill, 2007 sought to provide for benefits and compensation to people displaced by land acquisition or any other involuntary displacements.  The Bill created project-specific authorities to formulate, implement and monitor the rehabilitation process.  It also outlined minimum benefits for displaced families such as land, house, monetary compensation, skill training and preference for jobs.  A grievance redressal system was also provided for. Although the Bills were a step in the right direction, many issues still remained unresolved.  Since the Land Acquisition Bill barred the civil courts from entertaining any disputes related to land acquisition, it was unclear whether there was a mechanism by which a person could challenge the qualification of a project as “public purpose”.  Unlike the Special Economic Zone Act, 2005, the Bill did not specify the type of land that could be acquired (such as waste and barren lands).  The Bill made special provision for land taken in the case of ‘urgency’.  However, it did not define the term urgency, which could lead to confusion and misuse of the term. The biggest loop-hole in the Rehabilitation and Resettlement Bill was the use of non-binding language.  Take for example Clause 25, which stated that “The Government may, by notification, declare any area…as a resettlement area.” Furthermore, Clause 36(1) stated that land for land “shall be allotted…if Government land is available.”  The government could effectively get away with not providing many of the benefits listed in the Bill.  Also, most of the safeguards and benefits were limited to families affected by large-scale displacements (400 or more families in the plains and 200 or more families in the hills and tribal areas).  The benefits for affected families in case of smaller scale displacements were not clearly spelt out.  Lastly, the Bill stated that compensation to displaced families should be borne by the requiring body (body which needs the land for its projects).  Who would bear the expenditure of rehabilitation in case of natural disasters remained ambiguous. If India is to attain economic prosperity, the government needs to strike a balance between the need for development and protecting the rights of people whose land is being acquired. Kaushiki Sanyal The article was published in Sahara Time (Issue dated September 4, 2010, page 36)