Pharma industry has taken serious objection to the health ministry directive issued to all the states and union territories instructing the respective drug licensing authorities to grant or renew licenses to manufacture for sale or for distribution of drugs in generic names.
While Dr BR Jagashetty, Karnataka drugs controller declined to comment as he has not received any such communication as yet, the pharma industry in Karnataka and other states have been vociferous about the issue.
“The health ministry announcement has confused the industry and drug manufacturers are confounded with apprehensions on whether they would be able to exist in this line of business. The health ministry has depicted its poor understanding of the pharma sector which is a knowledge based industry generating $11.25 billion as export earnings. The directive is seen to be a direct hit on the pharma sector and its implications are seen as detrimental, pointed out industry officials.
According to N Jatish Seth, vice chairman, Confederation of Indian Pharmaceutical Industry (CIPI) and director, Srushti Pharmaceuticals, the directive would pose a lot of problems. For branded drugs, licences are valid for a period of five years. So companies who are seeking for the licences will not receive the same. This would disrupt not just revenues but the whole process of production.
The rational behind this directive is unclear. The government has done it again without taking the industry view on this. One wonders how the whole process would work and if India was armed for an generic drug regime. In the US and EU specially Germany, there are extensive generic product promotions and the brand name is only held with the innovator. The pharmacy chains promote the generics drugs backed by the bioequivalence studies carried on these drugs. There is no such practice in India, therefore the directive is seen to make no business sense, added Jatish.
SG Biligiri, president, Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) and technical director, Juggat Pharma said that directive was a catastrophe and was a serious blow of the pharma industry.
According to Kaushik Desai, immediate past chairman, Industrial Pharmacy Division, IPA, although it is a noble effort by the government, there are serious difficulties in its implementation. The big issue is the ability of the industry to adhere to these guidelines. The directive is ridden with administrative issues and there is no clarity on what happens to the brands for which licenses are already issued. There is need to have a central data bank of all the drug licenses issued for better monitored. In fact, it is the right time for the government to take a decision on the National List of Essential Medicines (NLEM) to make drugs more affordable.
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“We view this order as an abrupt announcement with no direction whatsoever. Today pharma companies are identified in the market with brand names now with generics they will lose their identity. But companies will now get a patent for brand and add the name to the generic version, said an official representing a leading pharma company” on condition of anonymity.
Bangalore District Chemists and Druggists Association viewed the directive to benefit the patients. For instance, Zydus Atrovastatin brand is priced at Rs.104.50 per strip and another branded version is available at Rs.10 for a strip. It is good move because there are multinational pharma companies which promote both branded and unbranded versions. The latter is sold at a ceiling price.