Mumbai: The US Food and Drug Administration, or FDA, is increasing scrutiny on all Indian drug exporters to the US on the back of the country’s largest drug maker by sales Ranbaxy Laboratories Ltd’s alleged forgery of quality compliance documents.
There are at least a dozen firms across India that supply drug ingredients exclusively to regulated markets as contract manufacturers for US and European drug makers.
Keeping vigil: FDA commissioner Andrew C. von Eschenbach. The US food and drug regulator is stepping up scrutiny on Indian drug firms following Ranbaxy’s alleged forgery of quality compliance documents. Photograph: Harikrishna Katragadda / Mint
The list of such firms includes Suven Pharmaceuticals Ltd, Divi’s Laboratories Ltd, Dishman Pharmaceuticals and Chemicals Ltd and Neuland Laboratories Ltd.
These companies are worried that despite sticking to stringent quality norms laid out by FDA as well as their customers, the big US drug makers, since their business model is to cater to regulated markets, stricter vigilance will not only lead to increased cost but also create unnecessary hurdles and delays in approvals and clearing of shipments of such drugs.
Early July, the US department of justice moved a local court against Ranbaxy, alleging the company submitted forged documents to prove quality compliance. Over 60% of Ranbaxy’s revenue comes from the US and Europe.
“We get a sense from the recent communications of the US agencies that the FDA will make sure there are more stringent measures to ensure quality compliance, and more detailed disclosures from Indian manufacturing sites,” says Sucheth Rao, chief operating officer of Hyderabad-based bulk drug manufacturer Neuland, which makes high-end but low-volume drug ingredients for regulated markets including Japan, besides the US and Europe.
“The apprehension in the US now is that the Indian companies are not meeting regulatory norms, and US companies are outsourcing (to India) only to increase margins and often compromising on quality,” says Gopal K. Nair, a Mumbai-based pharma manufacturing and quality regulations consultant.
“Our biggest fear is India might be dubbed as an inferior quality manufacturing location in the international market,” said another senior executive with an Indian bulk drug supplier to multinational clients who doesn’t want his or his company’s name to be identified.
China is already viewed with suspicion in the US after several cases of inferior quality drugs, including a recent case of batches of contaminated heparin raw material that killed 149 people in the US, were traced to a Chinese location.
The Indian industry is now worried that it may be viewed with the same suspicion, if the charges on Ranbaxy is proved in a US court.
FDA, which has now been given more money to strengthen overseas site inspections, after the US Congress set out a series of reforms in April that it believes will enable the regulator to better monitor the safety of food and drugs, is expected to focus more on India, as it does with China.
After a draft proposal of these reforms, the US media had quoted the congressional committee chairman, John Dingell, that “by strengthening protections against tainted imports and boosting FDA resources, this Bill will help assure Americans that the food on their tables and the medicine in their cabinets is safe.” The proposed Indian outfit of FDA will also help the agency increase the frequency of on-site inspections.
The drug industry lobby in India is worried about the developments. “The (Ranbaxy) incident is very unfortunate for the Indian generics and it would create reputational issues for the sector,” D.G. Shah, secretary general of Indian Pharmaceutical Alliance, an industry body of top Indian drug makers, had told Mint in an earlier interview.
According to him, patented drug makers could gain if quality concerns are raised about cheap generic drugs.
However, not all drug exporters are losing sleep over it. “As of now, I don’t see any effect and it’s too early to tell,” said Venkat Jasti, chairman and managing director of Suven Pharmaceuticals, a bulk drug exporter and contract researcher based in Hyderabad.
“One is not guilty until proven otherwise. This may be an indirect tariff barrier and Ranbaxy may come out clean with only a warning,” he said.