The Centre has called an urgent meeting of the Drugs Consultative Committee (DCC) on October 27 to fast-track its ambitious project of generating national data on quality of drugs manufactured and marketed across the country. The main focus behind this single agenda meeting is to finalise the matters in consultation with the state drug controllers for initiating the whole process at the earliest.
This meeting is perceived to be strategically very important for the pharma industry, as it will set the ball rolling for a very extensive and well organised effort by the government to have India's own official report on spurious drugs. Through this joint effort between the state and the centre, India will now be able to project a clear statistics on spurious drugs, thus clarifying India's stand on the same with scientific evidence.
Dr G N Singh, drug controller general of India (DCGI) informed that they have already formulated a plan through consultation with National Institute of Biologicals (NIB) for conducting a scientific study on the extent of problems of spurious drugs and drugs not of standard quality (NSQ).
He said, “We have already devised a survey plan to develop statistical drug sampling and a methodology, which we will appraise it to the state drug controllers and others stakeholders. In fact this meeting will be exclusively held to discuss about the design and modalities to be adopted for such a study at the national level and to assess the extent of the problem of spurious drugs and NSQ. Once we are through this study India will be able to scientifically prove that India manufactures and produces only standard quality drugs unlike claimed by vested interest. It will also finally help in addressing all the doubts and lack of confidence in the effectiveness of the Indian regulatory system and capabilities the drug regulators.”
It is understood that the government is very keen on pushing this initiative to ensure that the Indian pharma industry will get the resultant boost of confidence. As a follow up of this meeting the Centre had already asked the respective state licensing authority(SLA's) to submit a detailed report on the number of chemist and pharmacy shops in the state, number of drug testing labs along with data on samples collected, number of manufacturing units, licences issued etc.
Dr H G Koshia, commissioner, Gujarat Food & Drugs Control Administration (FDCA) stressed that from a regulators point of view this is a huge pro active step towards strengthening the credibility of Indian pharma industry further through a dedicated scientific based evidence. “Not only will this study help in positioning India as a strong pharma leader globally, as we will have strong data to support our point. It will also help putting a lid on all the detractor who try to malign the interest of the country through unjustified data and sources.”