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 Justice Srikrishna Committee, which is looking into the feasibility of a separate Telangana State, is expected to submit its report by tomorrow. It might be useful at this point in time to revisit the recommendations of the 1953 States Reorganization Commission (SRC) – the Commission that had first examined the Telangana issue in detail. However, it must be kept in mind that some of those arguments and recommendations may not be applicable today. Background Before independence, Telangana was a part of the Nizam's Hyderabad State and Andhra a part of the erstwhile Madras Province of British India. In 1953, owing to agitation by leaders like Potti Sreeramulu, Telugu-speaking areas were carved out of the Madras Province. This lead to the formation of Andhra Pradesh, the first State formed on the basis of language. Immediately afterward, in 1953, the States Reorganization Commission (SRC) was appointed. SRC was not in favour of an immediate merger of Telangana with Andhra and proposed that a separate State be constituted with a provision for unification after the 1961/ 62 general elections, if a resolution could be passed in the Telangana assembly by 2/3rd majority. However, a 'Gentlemen's agreement' was subsequently signed between the leaders of the two regions and this lead to a merger. The agreement provided for some safeguards for Telangana - for instance, a 'Regional Council' for all round development of Telangana. Thus, a unified Andhra Pradesh was created in 1956. In the years that followed, Telangana continued to see on-and-off protests; major instances of unrest were recorded in 1969 and in the 2000s. The SRC 1953 report The full SRC report can be accessed here. Summarized below are its main arguments and recommendations related to Telangana. Arguments in favour of 'Vishalandhra'
Arguments in favour of a separate Telangana State
SRC recommendations The Commission agreed that there were significant advantages in the formation of 'Vishalandhra'. However, it noted that while opinion in Andhra was overwhelmingly in favour of a larger unit, public opinion in Telangana had still to crystallize. Even though Andhra leaders were willing to provide guarantees ensuring development focus on Telangana, the SRC felt that any guarantee, short of Central Government supervision, could not be effective. In addition, it noted that Andhra, being a relatively new State, was still in the midst of developing policies related to issues like land reform. Thus, a hurried merger could likely create administrative difficulties both for both units. The SRC thus recommended the creation of a separate Telangana State with provision for unification after the 1961/62 general elections.
