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India’s regulator DCGI plans inspection of overseas drug manufacturing facilities

Monday, May 18, 2009, 14:27 This news item was posted in Legal, Pharma category and has 1 Comment so far.


India is yet to start the practice of inspecting factories abroad that export drugs to the country. 

India’s drug regulator Drug Controller General of India (DCGI) is planning to start the practice of sending its drug inspectors to countries which export drugs to India to ascertain and certify the manufacturing quality of the pharmaceutical products.

Even though India is one of the leading exporters of pharmaceutical products to different regions of the world, the country also imports drugs, active pharmaceutical ingredients (APIs) and drug intermediates from foreign countries like China and Taiwan.

Last year, India imported pharmaceutical products worth Rs 1500 crore from various countries, according to official figures.

However, it is not still a practice for India to visit the manufacturing facilities to conduct inspections to ascertain the qulaity of medicines being sourced by Indian companies. 

Most of the countries importing pharmaceutical products made in India send their personnel to visit Indian manufacturing facilities to verify and authenticate the manufacturing standards to ensure quality of the products before giving okay for importing.

“Inspectors from other countries, from Nepal to the US, come to India to check manufacturing facilities of Indian drug companies.

India also get drugs imported from many countries such as Taiwan and China for which we will start sending our inspectors to examine whether they are following good manufacturing practices,” stated Dr Surinder Singh, Drug Controller General of India (DCGI) who heads India’s apex drug regulatory body.

India will also soon start this practice close in line with the other countries, said Dr Singh. But he did not reveal much on the nature and time of such overseas inpections.

Currently, India has nearly 100 pharmaceutical manufacturing facilities approved the US Food and Drug Adiministration. This is the largest number of facilities outside the US, approved to source pharmaceuticals by USFDA -which sets one of the world’s most stringent quality parameters. USFDA conducts inspections periodically before giving approval for each pharmaceutical product to ensure that it follows the good manufacturing practice (GMP) standards set by the federal regulator.

If caught for any lapses, even minor, including the errors in documentations, USFDA instantly go for immediate action.

Show cause notices have been sent out by the US FDA for several of Indian manufacturing facilities including that of Ranbaxy, Wockhardt, Sun, Lupin Cipla etc over the years, after finding manufacturing errors during inspection in their USFDA approved facilities.

Most recently, US FDA even went to the extend of suspending the certification of Ranbaxy’s formulations manufacturing facility Paonta Sahib for not following set procedures. This followed a ban in importing products manufactured in Paonta Sahib, inflicting huge losses to Ranbaxy. Ranbaxy, now a subsidiary of Daiichi-Sankyo of Japan is one of India’s leading drug exporters to US.

Similarly, US FDA has also issued notices to Cipla, another big time export of pharmaceutical products from India.

Manufacturing facilities of Indian drug makers are also inspected and audited by MHRA of UK, ANVISA of Brazil, MCC of South Africa, TGA of Australia etc.

Therefore, it’s hightime India too started the practice of inspecting to bring in more transparency into the drug approval system, the DCGI said.

The pharmaceutical exports from India for the first nine months of the fiscal 2008-09 have peaked upto $1.2 billion, despite a slowdown in overseas trade across all industries owing to recessional fears.

Total exports in pharmaceutical products from India in December 2008 surged by 46.3 per cent to 1.01 billion dollars from 609 million dollars in the same month of the previous fiscal, according to Pharmaceuticals Exports Promotion Council (PHARMEXCIL) – separate governing body to oversee pharma exports under the Ministry of Commerce & Industry.

The overseas sales in the first nine months of 2008-09 went up by 21 per cent to 8.44 billion dollars against 6.97 billion dollars in 2007-08.

Despite this, India’s pharma exports to US is severely hit in recent months by increasing competition from other emerging markets like China, Israel and Korea, said a study conducted by Federation of Indian Chambers of Commerce and Industry –an umbrella association representing Indian businesses.

Pharmaceutical export business remains the worst hit among all the industries due to the economic down turn in US. Indian exports of pharmaceutical products to the US fell almost 40 per cent in the five months between October last year and the end of February.

Exports of pharmaceutical products from India have been facing steady competition in the US market from its Asian peers such as China and South Korea as well from Israel. In fact Indian pharma companies are increasingly losing their relative share to firms from these emerging economies.

The pharmaceutical exports from India for the first nine months of the fiscal 2008-09 have peaked upto $1.2 billion, despite a slowdown in overseas trade across all industries owing to recessional fears.

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One Response to “India’s regulator DCGI plans inspection of overseas drug manufacturing facilities”

  1. KVR SUDHIR said on Sunday, December 20, 2009, 2:06



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