Union government will now augment the compliance records of the Indian pharma industry with its slew of recent regulations, said Dr BR Jagashetty, National Advisor, (Drugs Control), and Project in-charge for the implementation of two schemes of Central Drugs Standards Control Organization (CDSCO).

The regulations covering Uniform Code for Pharma Marketing, Formation of Task Force to formulate Bulk drug policy, Medical devices policy, creation of Price Monitoring and Resource units in the state drugs control department and the Draft Amendment to the Drugs & Cosmetics Act 2015 would strengthen the Indian pharmaceutical sector, he added.

“These regulations signal the opportunity of Indian pharma sector across the large, medium and small industries to succeed in a stringent and competitive market conditions globally, stated Dr. Jagashetty.

The draft Drugs & Cosmetics Act (Amendment) Bill 2015 is a chance for the industry to comment and deliberate about the said norms.

Among the interesting inclusions in the draft Drugs & Cosmetics Act (Amendment) Bill 2015 is the penalty clauses. “The penalties indicate that both pharma industry and pharmacy trade will not be able to exploit and embark on unfair practices. It will also bring in transparency and accountability,” said Dr Jagashetty.

Another key aspect of the draft Drugs & Cosmetics Act (Amendment) Bill 2015 is the introduction of Central Licencing Authority (CLA) along with State Licencing Authority (SLA) for Schedule III. The CLA now replaces the Central Licensing Approval Authority (CLAA). We now need to see how the state drugs control departments accept the CLA, he said.

Commenting on the Medical Devices Policy, Dr. Jagashetty said that it was vital to include the same in the draft Drugs & Cosmetics (Amendment) 2015 because it was related to patient care. The recent foreign direct investments (FDI) policy permits 100 per cent FDI in medical devices sector through the automatic route. This mandates monitoring sale and manufacture of medical devices in the draft Drugs, Cosmetics and Medical Devices Act (Amendment) 2015, he said.

The enforcement of a Uniform Code of Pharmaceutical Marketing Practices (UCPMP), issued by the Department of Pharmaceuticals beginning this year, would thwart unethical practices of bribing medical practitioners by the pharmaceutical companies, said Dr. Jagashetty.

The price monitoring and resource units (PMRUs) in States and Union Territories to successfully track violations of drug prices fixed by National Pharmaceutical Pricing Authority will now put in place a mechanism for price audits, he said.

The Indian bulk drug industry also needs a dedicated policy and this is because active pharmaceutical ingredients (APIs) are core of any formulation. Therefore formation of a Task Force to formulate a policy is a step in the right direction by the government, said Dr Jagashetty.

Pharmaceuticals is a priority sector for the country. The government recognises that this industry is among its key growth propellers and went ahead to unveil the much wanted regulations, noted Dr Jagashetty.