The drug regulatory mechanism in India is currently undergoing a fine-tuning process to bring in more stringent and most modern regulatory measures for pharmaceutical and clinical research segments within a short period. The system, in lines with the regulatory mechanisms of some of the most regulated pharmaceutical markets in the west, will be established in India within a period of five years, according to Dr Surinder Singh, Drug Controller General of India (DCGI).
Delivering the keynote address in the 5th global conference on 'clinical research and drug development' in Mumbai, the DCGI added that the dug control office of India is working closely with the regulatory authorities like the US Food and Drug Administration (FDA), the National Health Surveillance Agency (Anvisa), Brazil and the Canadian regulatory agency - Health Canada for the betterment the drug regulatory mechanism in the country.
He said his office is working to include norms to allow basic research and phase 1 trials for foreign pharmaceutical companies in the country. The guidelines are prepared with the support of the US FDA, Anvisa and Health Canada.
The authority is also looking for various options to introduce specific guidelines and regulations for medical devices in lines with the foreign regulators. "We are working on many of the ideas to establish specific regulatory standards for medical devices in the country. One of the ideas is to bring in standards under the Global Harmonisation Task Force, but things are yet to be finalised," Dr Singh said.
The government is working on plans to restructure the regulatory standards by including separate specific quality and regulatory norms for various sections that slightly differs from the current concept of drugs and pharmaceuticals regulation, informed Debashish Panda, joint secretary, Ministry of Health and Family Welfare.
"We will be preparing separate provisions for drugs, clinical trials, medical devices, biotech products and various other closely related industries. The clinical research industry players should sit together, discuss the entire issues and come up with suggestions for the government. The government is expecting your suggestions and has already consulted many of the companies and experts for their views," he said. Panda deliberated that the government could think over setting up of an exports promotion council for clinical research, if the industry comes forward with such a suggestion.
The clinical research segment in India is mushrooming and companies are infusing more investment to the sector. The growth of clinical research industry will lead to requirement of more skilled manpower and the educational institutions have an important role to play in providing this manpower, said Panda.
The two day conference was organised by Institute of Clinical Research [India] (ICRI) as a platform for the clinical research experts to exchange their opinions and to devise a comprehensive overview of the rapidly expanding R&D segment. On the occasion, ICRI awarded Dr Nilima Kshirsagar, director, Maharashtra University of Health Sciences with Life Time Achievement Award and Dr S H Advani, medical oncologist, with Distinguished Investigator Award.
The ICRI's aim is to address the need of qualified and trained clinical research professionals globally by offering various programmes conveniently placed, and conducting the conference is to invite more knowledge and idea into the industrial segment, said S K Gupta, dean and director general, ICRI and the chairman of the programme committee.