DCGI APPROVAL MANDATORY FOR DRUG EXPORT

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DOMESTIC pharmaceutical companies can’t export medicines without the approval of central drug regulator Drug Controller General of India (DCGI) from next month, a health ministry official said.

The move is on the lines of the World Health Organisation’s (WHO) directive that discourages multiple certifying authorities in one country.

At present, companies can take state drug regulators’ approval to export medicines.

"DCGI has asked all state drug regulators to stop issuing export certificates (technically known as certificates of pharmaceutical product or COPP),” the official, who didn’t wished to be named, said.

DCGI has also curbed the power of state drug regulators for issuing the WHO compliance certification for good manufacturing practices (GMP). The central drug regulator will now be the sole authority to issue the GMP certification, he said.

"The WHO has time and again expressed concerns on the implementation of WHO certification scheme on the quality of pharmaceutical products moving in international community,” the official said.

There must be uniformity in issuing certificates to establish their authenticity and that is possible through a centralised system, he added.

In a letter to the state regulators, DCGI has said that certificates will be issued “by the central drugs standard control organization (CDSCO) after inspection of manufacturing facilities by CDSCO regulatory officials.” The office of the central drug regulator DCGI is known as CDSCO. Exports constitute about 40% of the Rs 75,000-crore Indian pharmaceutical market. Medicines manufactured in India are in demand in various parts of the world due to cost advantage. India also imports medicines worth Rs 15,000 crore.

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