India beefs up regulatory system and adds new office in Mumbai
This article was originally published in Scrip
India has launched a series of initiatives to strengthen its drug regulatory framework, including more than doubling its regulatory manpower and laying down guidelines for better monitoring of clinical trials.
India's minister of health, Ghulam Nabi Azad, said that the "sanctioned" strength of manpower at the country's Central Drugs Standard Control Organisation (CDSCO) had been raised to 327 from 111. "The major constraint of shortage of manpower in the regulatory authority has been resolved," Mr Azad said, adding that the immediate shortage of manpower had been met by engaging more than 300 professionals on a contractual basis.
Mr Azad, who was in Mumbai to inaugurate a new zonal office of the CDSCO, added that tie-ups with international regulatory agencies for training and capacity building had also yielded positive results.
The new CDSCO (West zone) arm has jurisdiction over the Indian states of Maharashtra, Madhya Pradesh, Chhattisgarh, Gujarat, Goa and the union territory of Daman and Diu and Silvassa. The Drugs Controller General of India, Dr Surinder Singh, said that it would offer "single window" regulatory clearance. CDSCO offices in Hyderabad and Chandigarh are also in the offing.
India has also strengthened its regulatory system for clinical studies. Last year, India had made registration of clinical trials mandatory on the website of the Indian Council of Medical Research (ICMR) and guidelines have also been framed for the registration of clinical research organisations (CROs), ethics committees and clinical trial sites. Dr Singh told Scrip that guidelines for registration of CROs had already been approved by the Drugs Technical Advisory Board and had been sent to the ministry for (issuing) draft notifications. These guidelines are expected to be incorporated as new Schedule Y1 in India's Drugs and Cosmetics Rules.
India has also introduced the Common Technical Document (CTD) format, which offers detailed information about the chemical and clinical development of products and is in line with International Conference on Harmonisation guidelines, for the submission of applications for the regulatory approval of vaccines. This is expected to facilitate the supply of Indian vaccines internationally. Large international companies, and Indian companies such as Serum Institute, Panacea Biotech and Cadila Pharma, have made submissions in the CTD format.