This segment of the newsletter is focused on regulatory reforms from Healthcare and Pharmaceutical sectors in the Indian jurisdiction with collated information on monthly basis via conducting research and appraisal of applicable statutory provisions. Presenting the highlights for the month of June 2019:

Cabinet passes new initiative to control Foot and Mouth Disease (FMD) and Brucellosis1

The Union Cabinet meeting chaired by the Prime Minister on May 31, 2019, cleared a novel initiative to control Foot and Mouth Disease (FMD), and Brucellosis, which is expected to improve the health of livestock and benefit crores of livestock rearing farmers. The Cabinet has allocated a total amount of INR 13,343.00 crores for this initiative with the aim to eradicate these diseases from the country in the next five years.

FMD and Brucellosis are very common amongst the livestock such as cow-bulls, buffaloes, sheep, goats, pigs etc. FMD in cow/buffalo has the potential to cause milk loss up to 100% which could last for four to six months. Brucellosis reduces the milk output by 30%, during the entire life cycle of the animal causing further infertility. The programme so far has been implemented on cost sharing basis between the Central and State Governments. In a rare instance of departure from the norm, the Central Government has decided to now bear the entire cost of the programme to ensure complete eradication of these diseases. The initiative envisages vaccination coverage for FMD to 51 crore animals at six months interval along with primary focus on bovine calves vaccination, while the vaccination coverage for Brucellosis is aimed to cover 100% of 3.6 crore female calves.

Health Ministry proposes implementation guideline for the 'Free Diagnostics Initiative'2

The Ministry of Health and Family Welfare under the support of National Health Mission launched the 'Free Diagnostics Initiative' in July 2015. The initiative was to provide the essential quality diagnostics accessible in public health facilities free of cost, which would further help physicians to take an informed decision regarding the treatment of patient. On June 08, 2019, the Health Ministry has proposed a set of implementation guidelines to ensure the availability of basic diagnostic services at public health facilities. This guidance could be useful for the states for rolling out or strengthening the free diagnostic services. Moreover, this document provides guidance about which services could be implemented in in-house laboratory and which services could be outsourced, if required. The guidance also explains the implementation of free diagnostics initiative in publicprivate partnership mode.

Health Ministry to boost the process of formulating 'National Policy for treatment of Rare Diseases'3

On June 11, 2019, the Union Minister for Health and Family Welfare at the high level meeting to review the status of 'National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Strokes (NPCDCS)' has directed the health officials to speed-up the process of formulating 'National Policy for treatment of Rare Diseases' and the Non Communicable Diseases (NCD) interventions in consultation of stakeholders as the burden of these diseases is continually rising in the country. The union minister also directed the officials to organize aggressive awareness drives at all levels to encourage public on adopting a healthy lifestyle and availability of nearby NCD Clinics and Day Care Centers.

Cabinet approves MoC between India and Kyrgyzstan on High Altitude Biology and Medicine Research4

On June 12, 2019, the Union Cabinet, chaired by the Prime Minister has approved a Memorandum of Collaboration (MoC) between India and Kyrgyzstan for collaborative research work on High Altitude Biology and Medicine. The MoC is aimed to develop and strengthen the mutual relationship in science and medicine sectors, especially in high altitude biology and medicine. Moreover, it will aim to understand the physical and mental condition of soldiers' system at high altitude, thus, easing the high altitude related maladies with Yoga practices, herbals and neutraceuticals in both Indian and Kyrgyzstan soldiers/population.

BPPI blacklisted 12 pharmaceutical companies for supplying substandard drugs to Jan Aushadhi Kendras5

Bureau of Pharma PSUs of India (BPPI), the implementing agency of Pradhan Mantri Janaushadhi Pariyojana (PMBJP), has blacklisted 12 pharmaceutical companies for supplying substandard medicines to Jan Aushadhi Kendras across the country, which are now barred from doing business for two years. The pharmaceutical products from these blacklisted companies were found substandard after testing in government laboratory; the companies being Overseas Health Care, Hanuchem Laboratories, Legen Health Care, Jackson Laboratories, Mascot Health Services, Syncom Healthcare, Osteoplast Wellness, AMR Pharma India Private Limited, Terrace Pharmaceuticals, Cachet Pharmaceuticals Pvt. Ltd., Ravenbhel Healthcare Pvt. Ltd. and Athens Life Sciences.







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