Bulk Drug Manufacturers Association (BDMA) has urged the office of the Drugs Controller General of India (DCGI) to set up an expert committee for scrutiny and inspections of pending applications for import registration of bulk drugs. Terming the decision of the government to extend the deadline for submitting the applications by another three months as disheartening, the BDMA wanted the government to utilize the extended period to draw up a technical pool of experts and professionals for the expert committee.
"We understand that the registrations are being routinely granted without an in-depth scrutiny or inspection of facilities etc. We request not to treat the import registration a routine fee collecting exercise," stated Venkat Jasti, president, BDMA, in a written plea to the DCGI.
The Association wanted the expert committee to be "drawn from the Government, research Institutions and Industry Association" so as to have capability to advise on the applications. BDMA felt that this move could ease the departmental pressures on scrutinizing these applications. "The pressures can be shared and minimized and the registrations expedited," they said.
The Association felt that a pool of experts from related fields like Industry, Research, Academics, FDA, Testing Laboratories and others including Government or Semi-Government organizations and corporations, will be equipped enough to undertake visits for inspection to the manufacturing premises of these applicants for import registration.
Recollecting that mandatory import registration has been a longstanding demand of the Association, Jasti felt that the registration will help the country in weeding out imports from unscrupulous manufacturers abroad and supplies of inferior quality and misbranding of the APIs (wrong declaration of the name and address of the manufacturer)."What is being proposed to be implemented is in tune with world practices, as it is a known fact that even smallest African countries like Tanzania and Nigeria wherein there is hardly any pharmaceutical Industry also insist for registration, as it is one of the major tools in the hands of the Regulatory Agencies to control the quality." He pointed out.
The Association wanted the import registration of bulk drugs for manufacturers / importers - procedures to be notified immediately.
"All the small countries make it a point to inspect the site to ensure compliance to cGMP requirement, inspite of the fact that some of the units which they are inspecting are approved under WHO scheme. The scrutiny of the documents will only give an indication of the status but as seen in practice that many companies who submit the best written documents, do get rejected for non-compliance. Inspection to the advanced countries will give exposure to the regulatory officers to the cGMPs followed by them and in case of developing countries, it will improve their inspection skills," it suggested.