“It is of vital importance to ensure that medicines and medical products produced in India are of the highest quality for both domestic and export markets. Within the Federal Democratic structure of the country, both the Centre and States are required to work together in harmony and synergy to ensure that we establish robust regulatory systems”. This was stated by Union Minister of Health & Family Welfare and Chemicals & Fertilisers Dr. Mansukh Mandaviya at the concluding session of the of the two-days brainstorming conclave on “Drugs: Quality Regulations & Enforcement”, here today. He was joined by Dr Bharati Pravin Pawar, Minister of State for Health and Family Welfare, Shri Bhagwanth Khuba, Minister of State for Chemical and Fertilisers, Dr VK Paul, Member (Health), NITI Aayog, Shri T Harish Rao, Health Minister, Telangana and Shri Sanjay Bhatia, Lokayukta, Upa-Lokayukta Maharashtra. Health Secretaries & Drug Regulators from various States/UTs also participated in the two-day long brainstorming conclave.
Dr Mandaviya further highlighted that the deep dive sessions of the Chintan Shivir provided a platform to all stakeholders to deliberate on different aspects of building a robust, resilient, transparent, accountable and citizen-friendly drugs regulatory framework. This framework will ensure not only quality, but easy availability and accessibility across the country of the highest quality of drugs and medical devises, he added. “The intense deliberations during the two days provided an opportunity to all the participants to work in a team spirit to deliberate on the building blocks of such a forward looking inclusive, holistic and comprehensive regulatory framework that would set the vision and meet the requirements of the next 25 years on the three levels of policy, priorities and implementation”, he highlighted.
Enthusing the participants, the Union Health Minister stated that “Our vision is to be known as the world’s most respected and recognised drugs regulator. This can only happen when we move from generic to quality-generic drugs and medical devices production in the country. Our drugs regulatory systems ought to meet the needs to R&D, innovation, organisation strengthening and capacity enhancement”, he stressed. “Quality by design” should be our motto, he stressed.
The discussions highlighted how to make the country’s drugs regulatory systems transparent, predictable and verifiable through principles of uniform standards, sturdy structures for compliance and enforcement, and capacity enhancement. It was also presented that technology can play role of a facilitator and enabler for uniformity, transparency and accountability. The need for a uniform portal with national database with integrated legacy systems was also discussed. Shifting from minimal to optimal standards with provision of periodic reviews, global benchmarking for not only drugs but medical devises formed integral part of the session today. Several participants underlined the importance of creating citizen facing measures to strengthen confidence on the quality of drugs along with portals for grievances, effective recall measures etc. In addition, oversight of supply chain was also proposed for quality assurance. In order to provide a platform to learn from the experience of other states, best practices of drug regulation from various states were shared by the state health representatives.
Dr Bharati Pravin Pawar appreciated the collaborative spirit with which Centre and states participated in the meeting. She also urged the industry representatives to bring out innovation solutions with particular focus on AMR which is emerging as a silent pandemic.
At the two-day Chintan Shivir, Dr Mandaviya led the participants for yoga and meditation sessions to promote healthy lifestyle practices.
Shri Rajesh Bhushan, Union Health Secretary, Smt. S Aparna, Union Pharma Secretary, Dr Rajiv Bahl, Secretary, Department of Health Research, Shri S Gopalakrishnan, Special Secretary, Union Health Ministry, Shri G Kamala Vardhana Rao, CEO, FSSAI, Dr Atul Goel, Director General of Health Sciences and Dr Rajeev Raghuvanshi, Drug Controller General of India were present on the occasion. Shri Rajiv Wadhawan, Joint Secretary, Ministry of Health & Family Welfare, Dr N Yuvaraj, Joint Secretary, Ministry of Chemical & Fertilizers and other senior officers and representatives from the Ministry of Health and Family Welfare, Ministry of Chemicals & Fertilizers, NITI Aayog, NPPA, DGHS, ICMR, NIPERs, Central Drug Laboratories also participated in the two-day long brainstorming conclave.