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:
Bihar became the first state to scrap the MLA Local Area Development Fund scheme (MLALAD). According to news reports, Nitish Kumar, Bihar’s Chief Minister, is planning to replace it with the CM Area Development Programme, which would be implemented at the District level. The schemes would be selected by a district selection committee headed by the minister-in-charge and MLAs and MLCs of that district as members. The implementation shall rest with a body of engineers, headed by Engineer-in-chief. The district magistrates would only monitor implementation and contractors would be chosen through open tendering in which a representative of the Comptroller and Auditor General of India (CAG) would be present. The state government would allocate funds as per requirement. The MPLAD and MLALAD scheme was introduced in December 1993 by former Prime Minister, P.V. Narasimha Rao to enable legislators to execute small works of a local nature to meet the urgent needs of their constituents. Under the scheme, each legislator may identify projects and sanction upto Rs 2 crore per year for public works in their constituencies. The scheme was mooted after MPs demanded that they should be able to recommend certain development projects in their constituencies. The projects include assets building such as drinking water facilities, primary education, public health sanitation and roads. The initial amount allocated was Rs 5 lakh per year to each MP. It has however not been smooth sailing for the scheme. Besides the many implementation lapses (as pointed out by the Standing Committee on Finance in 1998-1199, the CAG and the Planning Commission), the constitutionality of the scheme has been questioned by various scholars and experts. In 2002, the National Commission to Review the Working of the Constitution recommended immediate discontinuation of the MPLAD scheme on the ground that it was inconsistent with the spirit of federalism and distribution of powers between the centre and the state. Former MP, Era Sezhiyan in a booklet titled ‘MPLADS – Concept, Confusion and Contradictions’ also opposed the scheme and recommended that it be scrapped since it ran contrary to the Constitutional provisions which envisaged separate roles for the Executive and Legislature. However, the Committee on MPLADS in its 13th Report and its 15th Report stated that there was nothing wrong with the scheme per se except some procedural infirmities and recommended among other things a change of nomenclature to the Scheme for Local Area Development. The debate continued with the 2nd Administrative Reforms Commission’s report on “Ethics in Governance” taking a firm stand against the scheme arguing that it seriously erodes the notion of separation of powers, as the legislator directly becomes the executive. However, in response to a Writ Petition that challenged the constitutionality of the MPLAD scheme as ultra vires of the Constitution of India, in May 2010, a five-judge bench of the Supreme Court ruled that there was no violation of the concept of separation of powers because the role of an MP in this case is recommendatory and the actual work is carried out by the Panchayats and Municipalities which belong to the executive organ. There are checks and balances in place through the guidelines which have to be adhered to and the fact that each MP is ultimately responsible to the Parliament. Meanwhile, some MPs are pushing for hiking the amount allocated under the scheme to Rs 5 crore. However, no decision has been reached yet. The Ministry of Statistics and Programme Implementation has suggested that a single parliamentary committee be formed comprising of members of both Houses of Parliament to monitor MPLAD schemes. While the question of constitutionality of the MPLAD scheme may have been put to rest by the Supreme Court ruling, other issues related to implementation of the scheme still remain. Unless problems such as poor utilisation of funds, irregular sanction of works, delay in completion of works are tackled in an efficient manner, the efficacy of the scheme will remain in doubt.
