The Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare (MoHFW), Government of India along with the World Health Organization (WHO) organized two international workshops: International Workshop on Good Regulatory Practices for National Regulatory Authorities (20-21 July 2016) and WHO-CDSCO International Dissemination and Training Workshop on Drug Safety (22 July 2016) at New Delhi for strengthening of regulatory systems in India.
Mr K.L. Sharma, Joint Secretary, MoHFW said, “It is an historic meeting in which all the states of India as well as the central level regulators are on board to share their experiences on using customized WHO Global Benchmarking Tool and provide feedback to WHO.”
“The objective is to use the Good Regulatory Practices principles for strengthening the state regulatory authorities in India, including building their regulatory capacity, as outlined in the WHA Resolution 67.20 for strengthening national regulatory authorities,” he added
In line with the detailed Institutional Development Plan (IDP) developed following the WHO NRA Assessment for vaccines in December 2012, WHO and CDSCO have been working closely in a series of reforms and ongoing activities to strengthen the regulatory practices in the country. Additionally, the adaptation of the WHO NRA Benchmarking Tool is also being led by CDSCO under the guidance of the Ministry of Health & Family Welfare.
The first workshop was aimed at ensuring continuity of advancement and improvement of regulatory systems in the country within the context of the WHO Global NRA strengthening programme.
During this workshop, the centre and states shared their feedback about the adapted version of the NRA harmonized benchmarking tool with WHO. The second workshop was dedicated to drug safety issues and introduced regulators in India to the WHO Global Surveillance and Monitoring System for Substandard, Spurious, Falsely labelled, Falsified and Counterfeit medical products.
WHO plays a pivotal role in supporting countries in strengthening the regulatory systems of medical products for human use as per WHA Resolution 67.20 and in promoting equitable access to quality, safe, efficacious and affordable medical products. The Indian pharmaceuticals market is the third largest in terms of volume and 13th largest in terms of value. India is one of the main players in the pharmaceutical industry worldwide across all levels, pharmaceutical market, domestic manufacturing and overseas imports and exports.
Dr G.N. Singh, Drugs Controller General (India) outlined that effective regulatory systems are an essential component of health system strengthening and contribute to better public health outcomes, including the WHA Resolution 67.20, in which both central and state governments have a pivotal role.
An international team of experts from WHO, senior officials from the MoHFW, regulators from the central and state levels in India, officials from CDSCO and its affiliated institutions, including state drug controllers and drug testing laboratories participated and contributed to the deliberations.