New Delhi: Indian drug firms will soon have to approach the Centre rather than state authorities to get their facilities and export products certified, a move that industry players say could streamline the regulatory process for pharmaceutical sales overseas but add to delays.
The Certificate of Pharmaceutical Product (Copp) and good manufacturing practice (GMP), as laid down by the World Health Organization (WHO), will be issued by the national regulatory authority or the Drugs Controller General of India (DCGI) from 1 October, the government said in a notification last week.
Copp is mandatory in many countries that require WHO accreditation for products being imported. It will now be issued by the Central Drugs Standard Control Organisation (CDSCO).
The decision to take back the authority from the states was made during the 40th drug consultative committee (DCC) meeting in June, after several issues raised by WHO over the issuance of these certificates.
“The WHO has time and again expressed concerns on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce,” the government said in the notification.
“The standard for giving Copp certificates by the states is lax and if tomorrow the WHO comes and audits the facilities, we can have problems,” said a senior official with the health ministry who did not want to be named.
Indian drug firms have had issues with foreign regulators in the past year over standards at their manufacturing plants.
A year ago, the US Food and Drug Administration (FDA) issued warning letters and import alerts on Ranbaxy Laboratories Ltd for deviations from good manufacturing practices after it audited the firm’s plants at Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh.
The Indian pharmaceutical exports council, Pharmexcil, says the new system would help streamline exports. “This is a welcome step by the DCGI. It will help in the international market since it maintains uniformity and transparency,” said P.V. Appaji, executive director, Pharmexcil.
There were concerns, however, that possible delays at the Centre in issuing the certificates would lead to a delay in exports, he said. Till February, India’s pharmaceutical exports were worth Rs38,000 crore, a 30% growth over the previous fiscal year.
Small scale industries, too, are worried the move could hamper their exports.
“This decision of creating non-tariff barriers of centralizing issuance of Copp is just to please the MNCs (multinational companies), to kill the export competitiveness of the small sector against public interest,” said Lalit Kumar Jain, senior vice-chairman, SME Pharma Industries Confederation (Spic).