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:
The Piracy Bill was introduced in Lok Sabha on April 24, 2012. According to the Statement of Objects and Reasons, there has been a significant increase in attacks by pirates, particularly in the Gulf of Aden and off the coast of Somalia. This has affected security of maritime traffic and personnel plying between Asia, Europe and Africa. Moreover, enhanced naval presence in the Gulf of Aden is now causing pirates to shift operations close to India’s Exclusive Economic Zone. As a result, a number of Somali pirates are presently in the custody of Indian police authorities. However, since piracy as a crime is not included in the Indian Penal Code (IPC), this has led to problems in prosecution. The Piracy Bill intends to fill this gap and provide clarity in the law. The Bill, if passed by Parliament, would extend to the entire Exclusive Economic Zone of India (EEZ). Under international law, EEZ is a seazone over which a country has special rights for exploration and use of marine resources. It stretches outward from the coast, up to 200 nautical miles into the sea. The Bill defines 'piracy' as any illegal act of violence or detention for private ends by the crew or passengers of a private ship or aircraft on high seas or at a place outside the jurisdiction of any State. This definition is akin to the definition of piracy laid down under the 'United Nations Convention on the Law of the Sea'. The Bill seeks to punish piracy with imprisonment for life. In cases where piracy leads to death, it may be punished with death. It also provides that if arms, ammunition are recovered from the possession of the accused, or if there is evidence of threat of violence, the burden of proof for proving innocence would shift to the accused. The Bill empowers the government to set up designated courts for speedy trial of offences and authorizes the court to prosecute the accused regardless of his/ her nationality. It also provides for extradition. You can access the Bill text here.
