In a move to encourage hassle free exports, pharma companies have appealed to the government to extend the duration of the validity of licences like that of the Certificate of Pharmaceutical Products (CoPP) and Certificate of Good Manufacturing Practice (GMP) required under WHO certification to at least 3 years. The demand comes in the wake of growing discontent among the exporters over the bureaucratic delays and other complications they have to frequently face due to short validity period of only 2 years.

The Goa Pharmaceutical Manufacturers' Association (GPMA) has already raised its concern with the government and have apprised about the constant time strain and challenges the exporters have to face while applying for new licenses. As laid down by the World Health Organisation (WHO), CoPP and GMP certification is mandatory in many countries that require WHO accreditation for pharmaceutical products being imported.

At present the validity of the licenses is not more than 2 years which complicates the matter for the exporters who have to again go through the same cumbersome process in such a short while. Suresh Kamath, president of the GPMA stressed that the condition is becoming critical, as it is affecting the business interest, as every now and then the company have to file for renewing their licenses.

Kamath said, “The process of registration has become a nightmare for most of the exporters, as delay in getting the certification within the time frame is not only affecting their reputation in the overseas market but also is affecting their business prospects as well. This is mainly because of the long procedural delay caused due to the red tape prevalent in the system. Thus keeping in mind with the best interest of the industry, we have been in discussion with the top officials of the CDSCO over addressing this matter.”

A K Burman, immediate past president of GPMA, pointed out that there is an urgent need to extend the validity period further, as the time frame given for the licences currently is too short to do any long term benefit for the manufacturers. “Especially since, by the time exporters are finally ready to start the export activities, post certification and other regulatory requirements, the validity period of the licenses comes to the end. The government should pro actively support and work with the industry in sorting out this issue, so that the industry does not suffer further, at the critical juncture where it is already grappling with the challenges ensued by the changing market dynamics,”he added.