Need for a New Drugs Bill

After a legislative logjam (since 2011) with respect to regulating the pharmaceuticals industry, the new government at the centre has the opportunity to introduce the much-needed changes to the Drugs and Cosmetics Act. The amendment bill, introduced in Parliament on 29 August 2013, aimed to promote rational regulation of safe and effective allopathic drugs. That bill would have been yet another patch on an Act which has already been stretched beyond breaking point. It would have done little to provide a rigorous foundation for putting safety, effectiveness, rationality and need at the heart of the country’s drug regulatory system. It is to be hoped that the government will make a complete overhaul of the Act one of its highest priorities. 1 Background Following the scathing criticisms in 2012 of a parliamentary committee (59th r eport),1 India’s central drugs regulator, the Central Drugs Standard Control Organisation (CDSCO) headed by the Drugs Controller General of India (DCGI),2 was threatened with abolition and replacement by a central drugs authority (CDA), in the Drugs and Cosmetics (Amendment) Bill introduced in Parliament on 29 August 2013.3 The CDSCO was criticised in the 59th report for its pro-industry mission to “meet the aspirations...demands and requirements of the pharmaceutical industry”; for its apparently close cooperation with pharmaceutical companies in easing drug approvals and in avoiding legal requirements; for approving drugs without clinical trials, especially on Indian subjects; and for not exercising statutory powers to require licence revocation or drug bans. The committee also stated that “a very large number” of fi xed dose combination (FDC) drugs – formulations comprising two or more drugs combined in a fi xed ratio of doses and available in a single dosage form – had been approved by state regulatory authorities without prior central approval. FDCs are a peculiar feature of the Indian pharmaceutical market, compared to those on sale in England, the US or Australia.4 The Drugs Act of 1940 emerged from the Chopra Commission Report of 1931, on the need for central drug control legis lation with a view to securing uniformity throughout the country to control the import, manufacture and sale of drugs. It remains the core primary legislation regulating drugs in India today.5 It divided responsibilities between the central government (responsible for import) and the provinces or (today) states (responsible for manufacture, distribution and sale). Many amendments to the Act and the Rules have been introduced, o ften increasing central control.6 In 1952, the Rules introduced the concept of a “new drug”, requiring applicants to have the written permission of the central licensing authority prior to import.7 In June 1961 the Rules were further amended to prohibit the manufacture of a new drug unless it had been previously approved by the central regulator;8 to require the manufacturer of a new drug when applying for that approval to produce all documentary and other evidence relating to its standards of quality, purity and strength “and such other information as may be required including the results of therapeutic trials carried out with it”; and to require applicants for manufacturing licences to produce evidence to the state regulator that the new drug had already been approved.9 These provisions were amongst the fi rst which gave the central government increased control in relation to manufacturing; others included the powers of the central government to give directions to the states (1960);10 and to regulate, restrict and/or prohibit drugs on specifi ed grounds in the public interest (1982 and 2008).11 Nonetheless, several lacunae remain: (a) The need for a pre-approval duty on the regulator to be satisfi ed of the safety, effi cacy and effectiveness of new drugs; (b) The requirement for accountability and transparency in the submission of clinical trial results and data; and (c) The need to address the particular challenges posed by drugs supplied in fi xed dose combinations. We address these issues and then turn to an analysis of the proposed Act in the light of these requirements.