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Centre to augment compliance of India pharma with recent slew of regulations: Dr BR Jagashetty
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Nandita Vijay, Bengaluru
January 30 , 2015
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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.
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