Sun Pharma Asked to Halt Clinical Research in Mumbai
The Drug Controller General of India has ordered Sun Pharmaceutical, the country’s largest drug maker by market capitalisation, to suspend clinical research activities at its Mumbai based bio-analytical laboratory, a move that could slow down the company’s regulatory filings in India and possibly overseas as well.
According to officials familiar with the matter, the drug regulator took the step after discovering that Sun didn’t have the requisite approval from the central government for operating the laboratory. The drug regulator has decided not to accept future applications and won’t process existing new drug filings that Sun has made from the Mumbai lab until the company gets an approval. Sun has a similar laboratory in Vadodara.
Leading Indian drug makers have been facing increased scrutiny from global regulators with Ranbaxy Laboratories, Wockhardt and Strides Arcolab getting rapped by the US authorities earlier this year, but this is a rare instance of the domestic regulator taking stiff action against a company.
A final decision to suspend clinical research at the affected centre was taken at a meeting on Monday last week when senior Sun Pharma executives met top Drug Controller General of India (DCGI) officials to explain the company’s position.
This meeting was preceded by an exchange of correspondence between the company and central drug regulator’s office.
A Sun Pharma spokeswoman confirmed receiving a letter from DCGI and said the company was working with the authorities to resolve the issue quickly. She added that the company believed it has complied with all existing regulatory requirements.
It is rather unfortunate that ambiguity in guidelines has caused this situation,” said the Sun Pharma spokeswoman. According to an official, Sun had responded to a notice sent earlier this year by DCGI by saying the guidelines do not mandate an approval from the central government.
The company analyses sample results of the bioequivalence and bioavailability studies needed to file applications for new drug approvals.
The ban would impact new drug filings Sun has submitted to DCGI from that lab and may affect the new drug applications abroad.
The Sun spokeswoman didn’t reply to a query on whether it had used the Mumbai lab for filing new drug applications abroad. The company derives over 70% of its revenues from overseas markets.
While most leading drug makers do file applications in overseas markets using their bio-analysis bases in India, ET couldn’t independently verify whether Sun had filed any application from theMumbai laboratory in markets other than India. “Regulatory agencies in various markets have different demands for new drug filings. Almost all leading drug makers use their bioequivalence and bioavailability centres (BE-BA centres) to file new drug applications in overseas markets along with India by customising applications for different markets,” said a senior executive of a leading drug firm.
A government official said Sun’s other centre at Vadodara was also under scrutiny as some studies conducted there were linked to the Mumbai centre. However, submissions from that centre will be accepted for now as the necessary approvals are in place, said the official cited above.
The Sun spokeswoman said all other R&D work at Mumbai and Vadodara, including bio-analytical work at the second facility, remains unaffected. Sun Pharma rose 0.47% on Thursday to close at Rs 605 on the BSE.
Analysts said Sun may either have to shift its drug filings to other centres, such as the one in Vadodara, or outsource a part of its bio-analysis work until it gets the requisite approval.
“If it engages the services of external agencies, then the cost would increase. In case of change from Mumbai to Baroda, there may not be substantial increase in cost. Meanwhile, the company should be making all efforts for early resolution of the issue,” said Ranjit Kapadia, senior vice-president, Centrum Broking.
Every year, Sun typically brings about 30 new products to the Indian market, scales up 25 APIs (active pharma ingredients, the main raw material in a drug), including drug master files for the US and Europe, and develops and files for more than 30 ANDAs (abbreviated new drug applications) in the US, the company’s website says.
