The Central Drugs Standards Control Organisation (CDSCO), the Indian drug regulator states on its website in a document titled "Initiatives, Targets, Achievements (2001-2010)" the plan to set up India country offices in five countries to conduct regular overseas inspections of foreign manufacturing facilities and to verify good manufacturing practices and other statutory requirements.
It added that inspections abroad had already been started with six bulk drug manufacturing units in China inspected in May 2011 following which, import licence of one unit was cancelled. In March 2012, four manufacturing units in China were inspected and the registration certificate of one was cancelled.
When contacted the Drug Controller General of India (DCGI) Dr G N Singh confirmed that there were indeed plans to open offices abroad especially in countries from where India imports active pharmaceutical ingredients (APIs), used to manufacture drugs. "China is one of the main sources for APIs brought into India followed by Italy, the US and so on. We have to keep a close watch on the quality of APIs. Once we have more money we can inspect foreign units of Indian companies too," said Dr G N Singh adding that the funds would come out of the Rs 18,000 crore sanctioned for capacity building of the CDSCO.
However, the parliamentary committee differed. "The committee is of the firm view that physical inspection of overseas manufacturers of bulk drugs, apart from being cumbersome (serious language problem in countries like China, Korea, Cuba Hungary, Poland, documentation etc.) and expensive (due to sheer number of locations around the globe from Argentina to Turkey and multiple sites within one country) may not be the best option," said the committee report. It added that for the procedure to be effective, it would require a multi-disciplinary team which would have access to the manufacturing premises and documentation (in English) on GMP without advance notice to prevent manipulation; "a possibility given the serious manpower and infrastructure constraints of CDSCO is next to impossible".
According to the committee, it would be more practical cost effective and beneficial to collect samples of all imported APIs at the port of entry and get them tested here. CDSCO could get quality certification from the drug regulatory authority (DRA) of the country and if any of the imports were found to be of poor quality, it could blacklist the overseas manufacturer and also take up the case with the concerned DRA, recommended the committee. When asked how the CDSCO was proceeding with its plans despite the parliamentary committee's recommendations, Dr Singh said: "We have great respect for the parliamentary committee. But we are a science-based regulatory body and have to take science-based decisions. That's why we are going ahead with the plan. Why does USFDA have offices in other countries? To ensure safety of the medicines for their people."
However, Dr C M Gulhati, editor of the Monthly Index of Medical Specialties dismissed this argument of the DCGI stating that for Western regulators spending on inspections and establishing offices made sense as generics drugs they procured from India were 90% cheaper which ensured huge saving for their state-funded health services. "So they do it for the public not for drug companies," he said.
Dr Gulhati pointed out that barring some patented drugs, Indian imports comprised mostly cheap bulk drugs and formulations from countries like China and Egypt. "Why should public funds be spent on inspections abroad? It is the duty of importing companies to ensure that they buy quality bulk drugs and formulations. DCGI should mandatorily test all incoming shipments and charge the importers for such services apart from the conventional system of picking up samples from retailers. Unlike the West where generic drugs produced in India help the public and public health services, no such benefit accrues to the people or government here," explained Dr Gulhati. Inspections abroad or even setting up offices abroad, according to Dr Gulhati, were just "self-serving proposals for the benefit of babus".
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