This segment of the newsletter shares recent information related to regulatory reforms from Healthcare and Pharmaceutical sectors in India. This segment collates information on monthly basis via conducting research and appraisal of applicable statutory provisions. Below are the highlights for December 2019.

1. Government to launch AYUSH Export Promotion and Research Council

On December 19, 2019, the Ministry of AYUSH announced that Government of India will soon launch "AYUSH Export Promotion Council of India" and "AYUSH Export Research Council of India" to promote and facilitate the exporting community which may eventually increase exports.

The announcement came during the 2nd International Exhibition & Conference on AYUSH & Wellness sector - 'International Arogya 2019' jointly organized by FICCI with Ministry of AYUSH, Department of Commerce, Ministry of Commerce & Industry, and Pharmexcil. FICCI also launched a report on 'Understanding the AYUSH Services Market in India' during the event. Key takeaways of the report are:

  • The Ayurveda Services Market was estimated at INR 7,700 Cr in 2018, and is anticipated to more than double by 2024, growing at a CAGR 13.1%
  • The Domestic market is expected to grow at CAGR 10.2% during 2018–2024, while the Tourist segment is anticipated to grow at a CAGR 18.6% from 2018 to 2024.
  • 7,718 manufacturing units were engaged in manufacturing of Ayurveda drugs as on April 01, 2018, of which 99.5% were privately owned.
  • An upswing in number of accreditations started only in 2018, and it is anticipated to witness a sharp increase during 2019-2024, especially with the NABH coming up with an 'entry level' NABH certification in May 20191 .

2. Cabinet gave ex-post-facto approval to India and Bill & Melinda Gates Foundation (BMGF) on cooperation in the field of Health

On January 08, 2020, the Union Cabinet, chaired by the Prime Minister, has given its ex-post-facto approval on the Memorandum of Cooperation (MoC) between Department of Health & Family Welfare (DOHFW), Government of India and Bill & Melinda Gates Foundation (BMGF) on cooperation in the field of Health signed in November, 2019 during the visit of Mr. Bill Gates, Co-Chair and Trustee of BMGF to Delhi. The Memorandum of Cooperation (MoC) covers the following areas of cooperation:

  • To reduce maternal, neonatal and child morbidity and mortality, improve key nutrition outcomes, by improving the reach, coverage and quality of essential primary health, immunization and nutrition services.
  • To increase the basket of choice and quality for family planning methods, especially for reversible methods, and increase access amongst younger women.
  • To reduce the burden of select infectious diseases [TB, Visceral Leishmaniosis (VL), Lymphatic Filariasis (LF)].
  • To strengthen health systems, including aspects such as budget utilization, management and skills of human resources for health, digital health, strengthening supply chains and monitoring systems.
  • A Program Action Committee (PAC) will be set up to further elaborate the details of cooperation and to oversee the implementation of this Memorandum of Cooperation2 .

3. New pneumococcal vaccine from Serum Institute of India achieves WHO prequalification

On December 19, 2019, the Serum Institute of India (SII) has received Prequalification for PNEUMOSIL® from World Health Organization (WHO). This approval marks a milestone for SII towards improving affordability of pneumococcal conjugate vaccine and enabling sustainable access for low- and middle-income countries. PNEUMOSIL® is a vaccine against a leading cause of deadly childhood pneumonia. The vaccine was developed though a collaboration spanning over a decade between Serum Institute of India, Pvt., Ltd. (SIIPL) and PATH; and with funding from the Bill & Melinda Gates Foundation, the vaccine is expected to provide protection for children on par with other pneumococcal conjugate vaccines at a price that is more affordable for low- and middle-income countries.

Prequalification allows PNEUMOSIL® to be procured by United Nations agencies and Gavi, the Vaccine Alliance. This news marks an important milestone toward alleviating one of the biggest barriers – price - towards sustainable access to pneumococcal conjugate vaccine that countries face.3 .





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