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 budget process is covered by live TV and extensively by most newspapers each year. Most large companies have their own analysis of the budget. Increasingly, there is an effort by civil society groups to analyse the budget to decipher the allocations to the social sector. All of this is hugely important and indeed necessary for greater scrutiny and analysis by citizens across the country.
But we at PRS have often spoken about the role of Parliament in effectively scrutinising the government. If there is anything that the Parliament must scrutinise carefully each year, it is the budget – because this is the way in which the government expresses its real priorities. Even if the Parliament passes Bills on any subject – right to education, right to health, right to food, etc. – a good measure of the true willingness of the government to implement any of this can be seen by how much money it is willing to allocate to make things a reality.
Former Finance Minister Yashwant Sinha spoke about the budget process (Times of India, Feb 27th) and has argued that the current process in India is archaic and is in urgent need of an overhaul. He also points that Parliament has little power to change anything in the budget, and argues that this undermines the principles of our Parliamentary democracy. We agree.
On our part, we have produced two documents to help readers understand the budget process better. How to read the union budget and the Union Budget process can both be accessed from our website. And we would greatly appreciate your comments on this and other posts on our blog.
