Global benchmark for pharma sector on anvil

The government was contemplating uniform regulation for pharmaceutical companies irrespective of size, Ashwini Kumar, drug controller general (India), said in Kolkata on Saturday.

The country could not afford to have any sectoral differences within the industry, Kumar said. Quality and efficacy were two most important factors in the pharmaceutical sector regulatory framework.

"Since consumers are interested in quality and efficacy of drugs and not in whether the formulation has been manufactured by a small or big firm, we also cannot have any sectoral differences in this industry. We will have to create a level playing field," he said.

The government was planning to benchmark Indian regulations with international norms. "To reap the optimum benefit from export and outsourcing opportunities, we must integrate with the world. There cannot be different laws," he said at a meeting with the Bengal National Chamber of Commerce and Industry (BNCCI).

"The rules of the game change in export markets. The regulatory practices of a country cannot operate in an isolated manner. We cannot have only India-centric regulations for the drugs business," Kumar said.

International pharma companies operating in India have pointed out differences between the Indian regulatory regime and internationally accepted norms. The capabilities and benchmarks in the Indian pharma sector were being watched by the world.

The Indian pharma sector had grown from Rs 10 crore to Rs 20,000 crore in the last couple of years, and had been transformed from being a net importer to a net exporter. "It is imperative that industry personnel know more than regulatory personnel and go into an atmosphere of self-regulation," Kumar said.