International Conclave on Good Regulatory Practices in India

The World Health Organization (WHO), Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare (MoHFW) Government of India, along with the Government of Madhya Pradesh organized a two-day “International Conclave on Best Practices in Drug Regulation” at Bhopal on 21-22 August 2017 for strengthening of regulatory systems in India.

The objective of the conclave was to use the Good Regulatory Practices principles for strengthening the state regulatory authorities in India. It was a timely activity to bring all national and states regulatory counterparts on a single platform to facilitate capacity-building and enhance their understanding about the international and national best practices.

The conclave signified government’s strong commitment to have the best possible regulatory systems in this area.

In his inaugural address, Mr Faggan Singh Kulaste, Minister of State, Ministry of Health & Family Welfare, Government of India emphasized said that the Honorable Prime Minister of India, Mr Narendra Modi has a vision focusing on the universal health care agenda so as to provide all Indian citizens, regardless of their economic, social or cultural backgrounds the right to affordable, and quality medical products.

Speaking on the occasion, Mr Rustam Singh, Minister, Public Health & Family Welfare, Government of Madhya Pradesh said,“The conclave is expected to be an appropriate platform to enhance understanding about the international and national best practices in regulation of medical products thus bringing uniformity in the working style of various states.”

Speaking at the inaugural ceremony of the meeting, Dr Henk Bekedam, WHO Representative to India highlighted that WHO has been playing a pivotal role in supporting countries in strengthening their regulatory systems of medical products for human use, and in promoting equitable access to quality, safe, efficacious, and affordable medical products.

“WHO provides technical and operational assistance towards strengthening of India’s National Regulatory Authority (NRA). The endeavour is to scale-up the support to other product areas, including medicines at both, central and state levels,” he added.

An international team of experts from WHO, senior officials from the MoHFW, regulators from the central and states, officials from CDSCO and its affiliated institutions, including state drug controllers and drug testing laboratories participated and contributed to the deliberations.

Other prominent dignitaries at the inaugural were: Mr Sudhir Kumar, Joint Secretary, MoHFW; Mr Sudhansh Pant, Joint Secretary, Department of Pharmaceuticals; Mrs Gauri Singh, Principal Secretary, Health & Family Welfare, Government of Madhya Pradesh; Dr G.N. Singh, Drugs Controller General (India); Dr Pallavi Jain Govil, Commissioner, Food Safety and Controller FDA, Madhya Pradesh; Dr Alireza Khadem, Team Lead, Scientist, Regulatory System Strengthening, WHO HQ, amongst others.

India and regulatory systems for the pharmaceuticals industry

Effective regulatory systems are an essential component of health system strengthening and contribute to better public health outcomes. The Indian pharmaceuticals market is the third largest in terms of volume and thirteenth largest in terms of value. India is one of the main players in the pharmaceutical industry worldwide at all levels - pharmaceutical market, domestic manufacturing and overseas imports and exports. Amelioration, upgrading and global harmonization of the pharmaceutical industry in India would contribute to the global access to pharmaceutical, including medicinal, products of assured quality. CDSCO along with state drug regulatory authorities prescribe standards and measures for ensuring the safety, efficacy and quality of drugs, cosmetics, diagnostics and devices in the country.

WHO’s role in strengthening regulatory systems

WHO has been playing a pivotal role in supporting countries in strengthening their regulatory systems of medical products for human use, and in promoting equitable access to quality, safe, efficacious, and affordable medical products. Various World Health Assembly resolutions encompass aspects of the need to promote the quality, safety, efficaciousness and affordability of medical products.

WHO is also moving towards strategic alliances for training and capacity-building, including development of Centres of Excellence for Good Regulatory Practices (GRP) in Member States.

WHO provides technical, operational and financial assistance towards strengthening of India’s National Regulatory Authority (NRA). The endeavour is to scale-up the support to other product areas, including medicines at both, central and state levels.

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