Drug regulator gets six-month extension

Drug regulator gets six-month extension

Mumbai: The Union health ministry has granted a six-month extension to M. Venkateswarlu as drug controller general of India (DCGI).

He was to retire on Tuesday on turning 60.

The service extension, though only for six months as is the practice for interim extensions for most government posts, will result in the DCGI’s office pushing a few critical regulatory initiatives such as monitoring of human drug trials, a survey on spurious drugs and elimination of certain drug combinations which have questionable efficacy, Venkateswarlu said in an interview.

The DCGI will also initiate the so-called pharmacovigilance studies on Glaxosmithkline Plc.’s diabetic drug Avandia (chemical name: rosiglitazone) and Johnson & Johnson’s drug-coated heart stent Costar.

Concerns have been raised on adverse reactions on use of Avandia and its generic variants. The health ministry is expected to approve such actions proposed by the DCGI’s office.

Pharmacovigilance, also called Phase IV or post-marketing studies, is a comprehensive analysis of a drug’s side effects. Drug makers are bound by law to undertake such surveillance and submit data, collected from their panel of doctors, hospitals and patients, to the regulator, though some experts are sceptical of its efficacy in India.

The office of the DCGI, which was in focus as the Indian pharmaceutical industry witnessed unprecedented growth in terms of drug development and manufacturing, pharmaceutical service outsourcing as well as beginning of a number of new industry policy regimes in the past five-six years, has had no ‘permanent’ head since 1999, with both Venkateswarlu and his predecessor Ashwini Kumar holding additional charge of the key post.

The drug industry, which was upbeat about the recently expedited process of approvals for clinical research and other drug development projects, is apprehensive about the short tenures of such key posts.

Frequent changes in the leadership often affect the implementation of important regulatory initiatives, leading to inconsistency in policy, said an executive at a pharmaceutical company, asking not be identified.