The government has made it mandatory for domestic pharmaceutical companies to get prior approval of central drug regulator Drug Controller General of India (DCGI) from next month to export medicines.

The DCGI will issue Pharmaceutical Product (Copp) and good manufacturing practice (GMP) certificates from October 1 as underlined by World Health Organization. The move, though, will streamline the regulatory process for pharmaceutical sales overseas by discouraging multiple certifying authorities in one country but it may add delay in the process on account of over burden.

DCGI, in a fresh order, has also restricted state drug regulator to issue WHO compliance certification following concerns expressed by the body. The official added that uniformity in issuing certificates is possible only through centralized system.

The Rs. 75,000-crore Indian pharmaceutical market fulfills the drug demand worldwide by supplying drugs to many nations at very nominal prices. The country also imports medicines worth Rs 15,000 crore for its domestic needs.

P. V. Appaji, Executive Director, Pharmexcil, said, "This is a welcome step by the DCGI. It will help in the international market since it maintains uniformity and transparency."