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 15th Lok Sabha is close to the end of its tenure. A key legislation that proposes major reforms in food security was listed for discussion in Parliament. The National Food Security Bill, 2011 has been scrutinised by a Standing Committee. In January, we compared the Standing Committee's recommendations with the provisions of the Bill. Since then, amendments to the Bill have been introduced in Parliament. Debates on the Bill have revolved around the method of delivering food security, the identification of beneficiaries and the financial implications of the Bill. Method of delivery The Bill aims to make the right to food a statutory right. It proposes to use the existing Public Distribution System (PDS) to deliver foodgrain to 75% of the rural and 50% of the urban population. However, the Bill also allows for cash transfers and food coupons in lieu of grains as mechanisms to deliver food security. While the PDS is known to suffer from leakages as high as 40%, cash transfers and food coupons are known to expose recipients to volatility and price inflation. Each method of delivery would have its own implications, financial and otherwise. The table below compares these methods of delivery.[i] [table id=7 /]
Identification The Bill does not universalise food entitlements. It classifies the population into two categories of beneficiaries, who shall be identified by the centre and states. Mechanisms that aim to target benefits to certain sections of the population have been prone to large inclusion and exclusion errors. A 2009 expert group study headed by N.C. Saxena that evaluated PDS, estimated that about 61% of the eligible population was excluded from the BPL list while 25% of APL households were included in the BPL list. Beneficiaries under the Food Security Bill will be identified through a similar process. It is unclear how these errors in identification of beneficiaries under the PDS will be addressed by the Bill. Financial implications - cost sharing between the centre and states A Bill that aims to deliver food security to a large section of the country would have significant financial implications. Costs shall be shared between the centre and states. Costs imposed on states (partial or full) include: nutritional support to pregnant women and lactating mothers, mid-day meals, anganwadi infrastructure, meals for children suffering from malnutrition, transport and delivery of foodgrains, creating and maintaining storage facilities, and costs associated with District Grievance Redressal Officers and State Food Commissions. Although the centre shall provide some assistance, states will have to bear a significant financial burden on account of implementation. It is unclear whether Parliament can require states to allocate funds without encroaching on the powers of state legislative assemblies. If a state chooses not to allocate the necessary funds or does not possess the funds to do so, implementation of the Bill could be seriously affected. The Standing Committee examining the Bill had recommended that an independent body, such as the Finance Commission, should be consulted regarding additional funds to be borne by states. The Right to Education Act with similar centre-state sharing of funds provides for such a consultation with the Finance Commission. Cost of implementation of the Bill Another contentious issue is the cost of implementing the Bill. The Bill estimates the cost at Rs 95,000 crore. However, experts have made varying estimates on the costs ranging from Rs 2 lakh crore to Rs 3.5 lakh crore. Ashok Gulati, Chairman of the Commission for Agricultural Costs and Prices, estimated the cost at 2 lakh crore per year whereas the Minister of Food, K.V. Thomas was reported to have estimated the cost at Rs 3.5 lakh crore. The passage of the food security Bill in Parliament will depend on the ability of the government to build consensus on these issues. It remains to be seen how the Bill is debated next Parliament session.
[i] Kapur D., Mukhopadhyay P., and A. Subramanian. “The Case for Direct Cash Transfers to the Poor.” Economic and Political Weekly. Vol 43, No 15 (Apr 12-18, 2008). Khera, R. “Revival of the Public Distribution System: Evidence and Explanations.” Economic and Political Weekly. Vol XLVI, Nos 44 & 45 (Nov 5, 2011). Shah, M. “Direct Cash Transfers: No Magic Bullet.” Economic and Political Weekly. Vol 43, No 34, pp. 77-79 (Aug 23-29, 2008).
