3rd Annual Regulators Conclave for Central and State Regulatory Authorities in India

21-22 August 2019, Goa, India

The Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare (MoHFW) in collaboration with the World Health Organization (WHO) Country Office for India and the Government of Goa organised the 3rd Annual Regulators Conclave for Central and State Regulatory Authorities from 21-22 August 2019 at Goa, India.

The conclave aimed to further strengthen India’s regulatory system to provide equitable access to quality, safe, efficacious and affordable medical products, nationally and globally.

The pharmaceutical sector is one of the key 25 sectors identified by the Government of India under the Prime Minister’s ‘Make in India’ initiative, which is likely to provide the necessary impetus to the sector to achieve its true potential. The sector’s interface with the national regulatory authorities is, therefore, important as both have a vital stake in ensuring safety and quality of medical products.

“Regulatory system strengthening, and universal health coverage are the interlinked aspects for providing access to quality and affordable medicines. Local production needs to be fostered with stimulus packages for micro, small and medium pharmaceutical enterprises to leverage the true potential of the Indian SME sector for facilitating access to pharmaceuticals, diagnostics and medical devices. This conclave is an important step in this direction,” said Mr Ashwini Kumar Choubey, MoS, MoHFW during the inaugural address

Speaking on the occasion, Ms Preeti Sudan, Secretary, MoHFW said that “Universal health coverage is key to the Sustainable Development Goals 2030 agenda and India is firmly committed to it. Globally, the Indian pharmaceutical industry’s role in providing affordable quality medicines is well known. India has actively contributed and provided support for the new South East Asia Regulatory Network (SEARN) amongst the South-East Asian countries to guarantee access to high-quality medical products. The Government of India is committed to moving towards a world class regulatory system. The conclave would provide a platform for states and centre for strategic discussions on the regulatory functions to plan the next steps.”

Speaking at the inaugural session, Dr Henk Bekedam, WHO Representative to India, said that “India is playing a pivotal role in providing access to medicines worldwide. Indian manufacturers are the key contributors to the WHO Prequalification Programme (PQP) for medicines and vaccines. 64% of finished pharmaceutical products are from India and more than 60% of vaccines around the world are sourced from India. This achievement was made possible by the regulators and manufactures coming together for quality, safety and efficacy.”

The conclave deliberated on a range of cross-cutting issues, including further strengthening the regulatory system at the state-level, recent amendments to the Drugs & Cosmetics Rules, enabling ecosystem of clinical trials in India, regulatory landscape of medical devices, SUGAM portal and e-governance, moving MSME to WHO good manufacturing practices, strengthening safety monitoring, controlled human infection model studies - regulatory aspects, and WHO prequalification programme of medical products. The forum also took forward the recommendations of the two preceding annual meetings held at Bhopal and Kasauli in 2017 and 2018 respectively.

The conclave was attended by senior officials from the health ministry and allied ministries in the area of pharmaceuticals along with regulatory authorities from all 36 states and union territories. Other dignitaries present at the conclave were Mr J Ashok, Principal Health Secretary, Department of Health and Family Welfare, Goa, Mr Arun Singhal, Additional Secretary, MoHFW, Dr Mandeep Bhandari, Joint Secretary, MoHFW, Dr Manisha Shridhar, Acting HSD & Regional Advisor, WHO SEARO, Dr VG Somani, Drugs Controller General of India, senior CDSCO officials and senior WHO national and international experts. Industry representatives and relevant stakeholders, including the pharmaceutical and medical devices associations were also part of the event.