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India to prevent low-quality drugs imports from Chinese firms

Wednesday, June 16, 2010, 16:07 This news item was posted in APIs, Featured category and has 0 Comments so far.

India is planning to check the flow of cheaper drugs and raw materials of substandard quality from China.

Currently, pharmaceuticals producing firms in India imports most of the raw materials used for the manufacturing of medicines from China.

These so-called raw materials active pharmaceutical ingredients (APIs) and their intermediate substances are supplied cheap by Chinese manufacturers.

Even though hundreds of India drug manufacturers are producing APIs, several of these firms procure the raw materials from Chinese sources they supply intermediates and other chemicals at far lesser costs compared to that produced in India.

Cheaper availability of these raw materials has resulted in an increasing level of substandard medicines currently being circulated in Indian and other non-regulated markets where Indian drug makers exports to.

As a measure to prevent this import of low quality raw material products, India’s health department has decided to send officials to inspect manufacturing units of API suppliers.

These officials will conduct inspections on the manufacturing facilities which registered in India for exports and ensure that they are following good manufacturing practices stipulated by India for exporting firms.

They will also verify that drugs supplied to India are made at units certified by government agencies, reports said.

India’s drug regulator Drug Controller General of India (DCGI) has been 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 for sometime now .

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 quality 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.

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