Indian pharma regulations should not change to suit others, says the Government

14-Oct-2012 - Last updated on 15-Oct-2012 at 09:17 GMT

Foreign manufacturers should pick up the extra work created by their regulations, says the Indian Government

Indian regulations should not change to suit Western GMP standards, according to the country’s Deputy Drug Controller.

At last week’s CPhI in Madrid, in-PharmaTechnologist.com spoke to S Eshwar Reddy about the widely held belief that Indian good manufacturing practice (GMP) compliance is lacking.

Reddy argued that plants in the country do comply with local laws, but that some foreign countries have additional requirements.

He said the extra criteria occasionally means Indian products do not fulfil those country’s expectations, but added that it is the importing authority’s responsibility to ensure their own specific standards are met.

“If the importing country has specific GMP requirements, that is their responsibility to audit the facilities,” Reddy told us. “It is the responsibility of the importing country not the exporting country.”

He added that before importing a product, drug authorities should visit the facilities to ensure their GMP standards are met; a similar model to those introduced in the US Food and Drug Administration’s (FDA) GDUFA (generic drug user fee act) and PDUFA (pharmaceutical drug user fee act) updates.

Dr Reddy, Deputy Drug Controller of India — Reddy discusses Indian pharmaceutical manufacturing affairs with in-PharmaTechologist.com

The customer is always right?

When we put the question of whether Indian manufacturers – which produce more than 40 per cent of the APIs (active pharmaceutical ingredients) used in theUSandEurope– should be more sympathetic with Western guidelines and regulations, Reddy said the opposite should be true.

He said Indian pharmacopeial standards are the same as those in other countries, and that any additional requirements made are the sole responsibility of the authority which issues them.

Of PDUFA and GDUFA specifically, Reddy said the amendments are to speed up approval of a drug for the American market, and therefore are not directly related toIndia.

He told us: “Being the Indian drug regulatory authority we don’t have any monitoring mechanism of other countries’ regulations. Each country has their own set of laws so Indian regulatory authorities don’t have any control.

“But that requirement should be in line with the regulatory bodies (in other countries). Any particular law should not deviate or affect the other countries’ regulations. Any law should be in line with the WHO (World Health Organisation) laws.”

Tightening regulations

We also asked Reddy about the 12 manufacturing plants which were recently shut down for environmental violations, and further probed about the quality of Indian manufacturing if something of such magnitude can happen.

However, he replied that the manufacturers closed down not because of quality issues, but because of their “business models.”

He said: “Because of their business models they are not able to comfortably comply with GMP, and also they are not able to have a real business after the changes. It is an almost natural occurrence, it is not by forcible closing down.”

Reddy added that the regulations will change from time to time, and as they become tighter it is inevitable that some facilities will be unable to comply and will close.

“The regulations always need to be tightened. We do that as and when it is required,” he said, adding that there are still more than 4,000 API manufacturers operating compliantly inIndia.