Pharma sector Current Affairs

Government constitute committee to make drugs more affordable

The Union Ministry of Chemicals and Fertilisers has constituted a committee of joint secretaries for ensuring enhanced affordability, availability and accessibility of drugs for the citizens.

The committee will suggest ways to make pricing policy in favour of poor patients.

Terms of reference of the committee

The committee will review the scope of Drugs (Price Control) Order 2013 (DPCO 2013) and suggest ways for strengthening the regulatory provisions of the order. It will also suggest ways to make DPCO 2013 more comprehensive in light of past experience of implementing the order.

It will also delve into making the existing mechanism for collection of market based data on prices of medicines more robust. It will also suggest ways for strengthening the existing pharmaceutical database management system.

It will also look at procedural improvements and process of re-engineering in National Pharmaceutical Pricing Authority (NPPA) to ensure better and quicker implementation of the government policy and bring greater transparency to reduce litigations and review petitions.

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NRAI gets highest WHO ratings for vaccine regulations

India’s vaccine regulatory body NRAI (National Regulatory Authority of India) was given the maximum ratings by the World Health Organisation (WHO) for vaccine regulations.

The ratings were given by WHO after completing the assessment of the status of the NRAI system against WHO NRA Global Benchmarking Tool and measured the maturity of the system in India.

Need for assessment

India is one of the main players in the pharmaceutical industry worldwide and often is referred as pharmacy of the world. India, as a large vaccine producing country, is currently supplying several vaccines to the United Nations agencies (UNICEF, WHO and PAHO). A fully functional NRAI is a pre-requisite for WHO prequalification of vaccines. One of the requirements to become eligible and retain prequalification status is to get assessed.

Key Facts
  • The assessment was done in respect of 9 different functionalities by a WHO team comprising lead experts in different areas from WHO Headquarters Geneva, WHO India Country Office, experts from several countries.
  • Based on it, NRAI was declared functional with a maturity level of 4 which is highest level as per currently evolved definitions in respect of 5 functions, and maturity level 3 in respect of 4 functions.
  • Maturity level 4 indicates good results and sustained improvement trends, while level 3 reflects systematic process based approach, early stage of systematic improvements, data availability regarding conformance to objectives and existence of improvement trends.
  • The result reflects growing maturity of NRAI emanating from a concerted effort by Government in consultation with WHO to build capacity and capability of NRAI over last several years.

About National Regulatory Authority of India (NRAI)

NRAI comprises the Central Drugs Standard Control Organisation (CDSCO), State Drug Regulatory Authorities, Adverse Events Following Immunization (AEFI) and Pharmaco-vigilance Programme of India (PvPI) structures at the Central and States levels.

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