Pharma producers' organisation against drug price control

Hyderabad: Even as the Government has decided to bring another 354 medicines under the purview of drug price control, the Organisation of Pharmaceutical Producers of India (OPPI) has opposed the move stating that such steps would prove detrimental to the health of pharmaceutical industry.

Addressing management students at `Healthcare & Pharma Summit' at the Indian School of Business (ISB) here on Saturday, the OPPI President, Mr Ranjit Shahani, expressed apprehensions that such controls might even lead to unavailability of drugs, thereby affecting the interests of the public.

Mr Shahani, who is also the Vice-Chairman and Managing Director of Novartis India Ltd, said the real issue of concern should not be the cost of medicines but access to medicines.

According to him, the cost of medicines constitutes only 15 per cent of the total healthcare expenditure. While only 35 per cent of the Indian population has access to medicines, 65 per cent still has no access. Expressing uneasiness over the complex decision matrix in the country pertaining to the pharma industry, he said the Ministry of Chemicals and Petroleum handles price control, the Ministry of Health and Family Welfare looks after drug regulatory authority, the Ministry of Finance deals with import tariff, while the Ministry of Commerce and Industry takes care of TRIPS/WTO obligations.

data protection


Stressing on the need to protect intellectual property rights of pharma companies, he said OPPI has asked the Government to enforce TRIPS compliance, reduce rigours of price control, ensure data protection, bring in deterrent legislation against counterfeit marketers and reduce import tariffs to ASEAN levels. According to him, data protection provides the much-needed impetus for pharmaceutical innovation and Indian patients would gain from the accelerated access to new medical therapies.

The data protection would also speed up launching of more world-class clinical trial management facilities. Citing the McKinsey estimates, Mr Shahani said the country could earn over $2-billion in the next few years from bio-informatics alone.

The Managing Director of Pfizer, Mr Kewal Handa, said over-regulation would prove a major threat to the Indian pharma industry. The Government's mindset on IP and patents was turning out to be a major hindrance to the industry. He opposed the draft law on price control terming it as draconian. He asked the Government to encourage a price structure that recognises and rewards innovation.

Condemning the current Indian regulatory environment, Mr Handa said the country has an ambiguous patents law passed in 2005, wherein patent examiner's guidelines are not yet in place and only one biotech patent was granted till date.

While there has been inordinate delay in decision on data exclusivity, the country is yet to have drug reimbursements in the absence of a vibrant health insurance sector, he said.