US, Indian drug authorities agree on regulatory cooperation

India and the United States on Monday signed an agreement, under which drug regulators of the two countries have agreed to cooperate on regulatory matters and establish better coordination between the inspectors of both the regulatory authorities.

US Food and Drug Administration (USFDA) commissioner Margaret Hamburg who is on an official visit to India signed a 10-point agreement with Keshav Desiraju, secretary in ministry of health and family welfare to coordinate regulatory measures.

The agreement comes after commerce and industry minister Anand Sharma raised concerns over the audit inspections of Indian pharma companies by the US Food and Drug Administration (USFDA).

Sharma is understood to have drawn the FDA commissioner's attention to the fact that most of the time, audit inspections were not followed by discussions with companies. In some cases clarifications were sought, but even before a response, harsh decisions were taken.

''Attention was also drawn to the disproportionate penalties imposed by USFDA on some companies,'' a commerce ministry official said.

The USFDA has, in recent times, been taking a series of actions against Indian pharmaceutical firms, restricting product shipments to the US, which is their largest export market.

Hamburg said the meeting was ''excellent''. She, however, did not comment further.

Speaking to reporters after a meeting with the Drug Controller General of India (DCGI) G N Singh later in the day, the FDA chief said the agreement would help improve patient safety and the quality of medicines and ensure a more scientific evaluation system.

The two regulators will utilise the experience of each other in their ongoing efforts at capacity building both in evolving systems for drug testing and in bringing about greater accountability in the governance of the system.

According to DCGI G N Singh, the collaboration would not only help India as well as the US since Indian manufacturers supply nearly 40 per cent of the total generic drug needs of the US.

Singh also pointed to the concerns of the Indian pharmaceutical companies regarding the generalisation of issue of problems connected with non-compliance with the USFDA.

Indian drug companies wanted non-compliance to be seen in isolation and not as some kind of indictment of the entire Indian pharma industry.

''We are going to give a non-paper (to the US) overall on some of our concerns, when it comes to duration for the registration process for the filing. They have the process of filing and the fee, those issues have been discussed. But it will be general, the paper, which I have suggested, we will give them,'' commerce minister Anand Sharma said after a meeting with the USFDA commissioner.

The non-paper would highlight India's concerns with a view to seek an early resolution on these issues.

The regulator, in January this year, had banned the import of products manufactured by Ranbaxy Laboratories at its plant in Toansa. This was the company's fourth plant to face regulatory action from the USFDA (See: US FDA raises concerns over a fourth Ranbaxy facility).

Another Indian firm, Wockhardt, has had two of its plants being put under import alert by the USFDA (See: Wockhardt gets another blast from US drug regulator FDA).

India also raised concerns over the high fees for certain services rendered by the USFDA and the delays caused in several approval processes.

Sharma said pharmaceutical issues were discussed ''very clearly'' as was cooperation in the sector.

''These issues do come up before the countries. What is important is the willingness to address those issues and resolve matters, which we have definitely mentioned,'' the minister added.