Govt wants its officials present during FDA inspections at pharma units

Hyderabad: Perturbed by Indian drug-makers frequently running into overseas regulatory problems, the government has requested the US health watchdog FDA to allow its officials during inspections of domestic pharma units.

 Govt wants its officials present during FDA inspections at pharma units

Representation image. GettyImages

While Indian pharma exports continue to grow and may touch $16.5 billion this year, many Indian pharmaceutical companies have faced regulatory action by the US Food and Drug Administration (FDA) in the recent past for alleged violation of 'good manufacturing practices' and other irregularities at the drug facilities in different parts of the country.

In many cases, these companies have been barred from selling their drugs in the US and other countries, although Indian firms account for a significant share of generic drug market in those places.

"US FDA's increased inspections and observations (under 483) also are troubling us. The Ministry of Commerce has taken up the issue seriously. Earlier practice was that whenever they are visiting any Indian site they used to inform us. Now they started coming without any notice.

PV Appaji, Director General Pharmexcil, (Pharmaceuticals Export Promotion Council), under the Ministry of Commerce and Industry also said that India pharma exports may touch $16.5 billion this year.

"Cultural differences and body language may sometime widen the gap (during FDA inspection). We are requesting them (FDA) to allow Indian regulators also to be present during the inspections," Appaji told PTI.

Indian pharma exports have come under tremendous pressure in the recent times owing to various import alerts issued by the USA drug regulator on some of the major pharma companies.

Describing India as a nation which is of "particularly important" to US food and drug trade, FDA Commissioner Margaret Hamburg had earlier said inspections are routine part of the regulatory process and what happens in India is consistent with what happens in the US and throughout world.

A number of other Indian drug-makers, including Ranbaxy, Sun Pharma, IPCA Labs, Wockhardt and Dr Reddy's Laboratories were also pulled up by the FDA for one or the other reasons.

The FDA imposed a ban on import of medicines produced at Ranbaxy's India-based factories into the US, the world's biggest drug market. Later, certain drugs produced at its Dewas plant were barred from export to the entire EU region for non-compliance to 'good manufacturing practice norms.

Sun Pharma also faced regulatory heat as the FDA put a ban on import of products made at its Karkhadi plant in Gujarat. Another pharma firm which ran into rough weather was Wockhardt, in whose US facility in Illinois, USFDA found many procedural lapses.

The US health regulator also found nine possible procedural deviations in a manufacturing plant of Dr Reddy's Laboratories during an inspection last year.

Ipca Laboratories' Ratlam unit was also found to be violating good manufacturing norms by USFDA
investigators.

"Last year Indian pharma exports grew by 2 percent. This year we are expecting the growth to be in the range of 8 to 10 percent. The USA market recovered well," Appaji said on the export performance.

India's pharmaceutical exports During April-November 2014 has been to the tune of $10.2 billion with a growth of nearly 5 percent over the corresponding period of 2013.

Two-thirds of exports are made to top 25 destinations and is valued at nearly $7 billion. Exports to USA stood at $2.9 billion for the April-November period against $2.5 billion during the same period last year, Appaji added.

PTI

Updated Date: Jan 11, 2015 13:07:39 IST