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:
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:
One of the main tasks of the Parliament is to frame laws through debate and discussion on the floor of the House. However, there have been repeated instances where Bills introduced by the government have been passed without substantive discussion (For news reports, click here and here). Even where Bills are debated extensively, occasions where the government introduces changes in the Bill directly as a response to Parliamentary debate are hard to find.
One recent exception is the list of amendments introduced to the National Green Tribunal Bill, 2010 by the Minister for Environment and Forests directly in response to issues raised on the floor of the House.
The Bill
The National Green Tribunal Bill, 2009 aims to set up specialised environmental courts in the country. It will hear initial complaints as well as appeals from decisions of authorities under various environmental laws. The Tribunal shall consist of both judicial and expert members. Expert members have to possess technical qualifications and expertise, and also practical experience.
The Tribunal shall hear only ‘substantial question relating to the environment’. Substantial questions are those which (a) affect the community at large, and not just individuals or groups of individuals, or (b) cause significant damage to the environment and property, or (c) cause harm to public health which is broadly measurable.
PRS in its analysis of the original (unamended) Bill, had raised the following issues (for detailed analysis, clickhere) :
The Debate
In the debate on the Bill in the Lok Sabha on April 21, 2010 a number of MPs raised substantive issues with respect to the Bill. Some of the issues raised were (From the news article quoted above):
1. The Bill fell short on parameters of “scope, efficiency, and access to justice”.
2. Setting up five benches while barring the jurisdiction of courts will “create huge distance for the poor community members and tribals to seek justice”.
3. Offenses under the Wildlife Protection Act and the Wildlife Protection Act will not be heard by the Tribunal.
4. “Section 15 puts an embargo against [persons] other than retired Judge of Supreme Court or Chief Justices of High Court. The other clause puts 15 years of administrative experience, which would open the path for packing the Tribunal with bureaucrats of the kind who did not enforce the environment related laws in their time in service.”
The Minister acknowledged the contribution of the members by stating that: “The members have made important suggestions. Even though their exact demands may not be part of the official amendments moved by the government… but I am open to their suggestions…I will remove all objectionable clauses or sections in the proposed law and keep the window of discussion open.”
The Minister’s response
In response to these issues, the Minister Mr. Jairam Ramesh introduced 10 amendments to the Bill on April 30, 2010. Though not all the issues raised were addressed, a number of changes were made. In addition, the Minister also assured the House that issues regarding access would be addressed by the government by following a “circuit” approach for the benches of the Tribunal i.e. the benches would travel around the area within their jurisdiction to hear complaints. (To read the response, click here, page 15250)
Some of the main amendments are:
1. Now any aggrieved person can can approach the Tribunal. Earlier limited access was provided.
2. The whole Act will be operational by notification at the same time. Different provisions will not be enforced separately at different points of time.
3. There is a procedure for direct appeal to the Supreme Court from the judgement of the Tribunal.
4. The number of expert and judicial members is clearly specified.
In addition, the Minister also assured that the Selection Committee for picking the members of the Tribunal will be transparent and will ensure that members are not “a parking place for retired civil servants”.
