A one-day workshop on regulatory systems in the pharma sector,was jointly organized by National Medical Products Administration (NMPA, erstwhile CFDA) and Central Drugs Standard Control Organisation (CDSCO) for the benefit of Indian pharmaceutical companies on 21st June, 2019 in Shanghai, China.

The intensive day-long workshop included detailed deliberations in areas such as regulatory overview of NMPA, registration of imported drugs in China, Indian regulatory system, drug procurement system in China, NMPA overseas inspections and compliance guide, API (Active Pharmaceutical Ingredient) registration process in China and compliance guide. Both sides also decided to work towards greater coordination and cooperation between the two regulators in the future.

India has requested China to open its pharmaceuticals market, especially for affordable and high quality generic drugs from Indian pharma companies. India has also asked China to clear the various regulatory hurdles faced by the Indian pharma companies on priority, including long delays in product approval timelines, lack of clarity in the current registration guidelines, waiver for bio-equivalence (BE) studies and local clinical trials, drug procurement by local governments in China, suomotu approvals for those Indian pharma companies which have approvals from stringent regulatory authorities like USFDA, EDQM, Japan and ‘risk based’ batch testing with self-certification. The steps taken to enhance and encourage the exports of pharma products, including high standard generics, from India to China are given below:

Steps taken for enhancing and encouraging exports of pharma products, including high standard generics, from India to China

1. Creating awareness among Indian pharma companies on the opportunities in China and guiding them to consider product registrations with CFDA to enable higher exports to China.
2. Circulation of the Chinese list of exempted 28 tariff items and the list of anti-cancer drug covered under these lines amongst the Indian Pharma industry.
3. B2B meet organized during 20-22 August 2018 at Shanghai, China which facilitated interaction of Indian Pharma companies with Chinese importers and officials of NMPA.
4. Creating awareness on the Regulatory requirement in China. Pharmexcil, with the support of Department of Commerce (DoC), organized a training program /workshop on product registration guidelines and dossier filing with the National Medical Products Administration (NMPA, formerly CFDA) for the benefit of our pharma companies on 17th December 2018 at Hyderabad.
5. MoU on cooperation in pharmaceuticals executed between Pharmaceuticals Export Promotion Council of India (Pharmexcil) and China Chamber of Commerce for Import and Export of Medicines and Health Products (CCCMPHIE) in August 2018.
6. Help Desk set up in Pharmexcil and CCCMPHIE to help companies from both sides in finding the right partners for their business ventures.
7. Under the India-China Strategic Economic Dialogue (SED) being co-chaired by NITI Aayog from the Indian side, a joint working group on pharmaceuticals has been set up by Department of Pharmaceuticals and the first meeting took place on 7th May, 2019 at Beijing wherein the issues impacting market access were raised by the representative of DoC for the consideration of Chinese authorities.
8. A one-day workshop on regulatory systems in the pharma sector was jointly organized by National Medical Products Administration (NMPA, erstwhile CFDA) and Central Drugs Standard Control Organisation (CDSCO) for the benefit of pharmaceutical companies on 21st June, 2019 in Shanghai, China.

This information was given by the Minister of Commerce and Industry, Piyush Goyal, in a written reply in the Rajya Sabha today.

Market access for Indian generics urged; China asked to ease regulatory barriers and streamline approvals to boost exports. A bilateral regulatory engagement sought to facilitate Indian pharmaceutical exports to China by addressing market access and procedural barriers. India requested China to open access for affordable generics and remove obstacles such as long approval timelines, unclear registration guidelines, local bio equivalence and clinical trial requirements, and mandatory local batch testing, while seeking recognition for approvals by stringent authorities and adoption of risk based batch testing with self certification. Complementary measures include training, B2B meetings, a Pharmexcil-CCCMPHIE MoU, help desks, and a joint pharmaceuticals working group under the Strategic Economic Dialogue.