The Pharmaceuticals Export Promotion Council of India (Pharmexcil) recently held a detailed discussion with some of the top officials of the ministry of health regarding the adverse impact of the order to state licensing authorities to grant or renew manufacturing licences only in generic names and not on branded names. The Council explicitly stated that the implementation of such a directive is uncalled for and will only hit the industry making it impossible to achieve the export target of $ 25 billion fixed for 2014.
The approach was made to the health ministry with a view to safeguard the interest of the industry that has a huge revenue coming through exports. The directive of the health ministry is seen as a huge burden for pharma exporters as from now on, they will have to get the Certificates of Pharmaceutical Products (CoPP) and the Certificate of Good Manufacturing Practise (GMP) under WHO certification also issued in the generic name. Earlier the CoPP certificate which is mandatory in many countries that require WHO accreditation for pharmaceutical products being imported was issued in the brand name.
According to Dr P V Appaji, director general, Pharmexcil,“Considering the huge amount of money and time the exporters put in marketing and building up their brand name at the international market it will be a huge monetary loss for the companies targeting exports. Moreover there is a lack of clarity on what exactly the directive implies when it comes to use of brand names. Our understanding is that the directive is not in the nature of prohibiting the brand name, but it is in the nature of not endorsing the brand name.”
He further pointed out that according to reports from the industry some state licensing authorities have already stopped endorsing brand names for exporting their products putting the exporters in a dicey situation. Exporters state that such a directive will have a significant impact on the growth of the industry as doubt and confusion looms over various aspects of this directive.
Dr Appaji informed, “After independent study and analysis on this issue, we have come to conclusion that this directive will have a negative impact on the industry and its growth story if not addressed. Thus with a view to ensure that the woes of the exporters are heard at the centre, we have already taken up this matter with the concerned officials and have made a presentation to them on the current problems faced by the exporters to push for further discussion.”
Acknowledging the seriousness of this issue, the commerce ministry has 'in principle' agreed and shown willingness to look into this matter at the earliest. Reports suggests that the industry has already started showing signs of slowdown which brings attention to the fact that this problem needs to be looked after on a priority basis.