DCGI may extend pharma export licence tenure

NEW DELHI: Hurdles faced by pharmaceutical companies while accessing global markets may ease now. The drug regulator’s office is likely to extend the tenure of export licence and other approvals from one year to at least three years. The move is expected to help many pharma companies that export huge quantities by reducing compliance cost.

The industry has also approached the drug regulator to increase the tenure of another certificate that importing countries insist on –– the certificate of pharmaceutical product (COPP) –– to a minimum of five years. The drug controller general of India (DCGI), who looks after the safety and efficacy of drugs and gives marketing approval, is now looking at increasing the tenure.

“Pharmaceutical exporters have been experiencing problems in international markets on account of delays in getting government approvals,” said Indian Drug Manufacturers Association (IDMA), International Trade, chairman DB Modi.
Currently, in India, companies get a COPP for a period of two years, after which exporters and manufacturers need to go through the process all over again to get their licences and certificates renewed.

The State Food and Drug Administration (FDA) generally issues COPP after a joint inspection of the manufacturing facility by inspectors from the Central Drug Standard Control Authority and State FDA. “Re-inspection is required to get the new COPP, but many a times re-inspection is not possible in time due to various constraints like limited number of staff available,” Mr Modi said.

According to Mr Modi, regulatory authorities in most of the countries do not accept COPP with a remaining validity of 6 months. The industry has, therefore, asked DGCI to ease the process by extending the period of their test licences. The industry has suggested that NOC may be issued for exporting a specified quantity of medicines to a particular country without looking at the time limit. While DCGI is looking into the possibility of issuing consolidated export approval for a longer period, it would also have to look into other aspects so that regulatory issues do not get compromised as import laws differ from country to country.