This segment of the newsletter shares recent information associated with regulatory reforms from Healthcare and Pharmaceutical sectors from in Indian jurisdiction. This segment collates information on a monthly basis via conducting research and appraisal of applicable statutory provisions. Below are the highlights for July 2019:
No timeline for Finalization of Draft Rules on Sale of Drugs by e-Pharmacies1
On June 25, 2019, the Minister of State (Health and Family Welfare), in a written reply in the Rajya Sabha informed the status of finalizing 'Draft Rule' on Sale of Drugs by e-Pharmacies. Earlier, the Government, on August 28, 2018, had proposed the draft rules for incorporating provisions relating to the regulation of online sales and distribution of drugs in Drugs and Cosmetics Rule, 1945. A large number of suggestions/ comments received from the public/ stakeholders in this matter are under examination, at the same time it is also sub judice before various Hon'ble High Courts in the country. Therefore, the Health Ministry stated that no timeline for finalization of the rules can be provided as of date.
While the 'Draft Rule' is yet to finalized, the Health Ministry directed State Licensing Authorities to take appropriate action under Drugs & Cosmetics Act if the sale of spurious drugs and violation of Act & Rule is reported in their jurisdiction.
World Bank supports "Treat and Eliminate Tuberculosis from India" program2
On June 27, 2019, the World Bank and the Government of India (GOI) signed a loan agreement of $400 Million to expand and speed up the interventions for the control of Tuberculosis (TB), which predominantly affects the underprivileged and marginalized population and kills almost half million people every year in India. The program aims to cover nine States of India via:
- Strengthening the diagnostics and management system of drug-resistant tuberculosis and capacity buildings of public institutions which are involved in TB management in the country.
- Ensure that private sector providers adhere to established protocols of timely diagnosis, notification and effective management of TB.
- Provide financial incentives to private care providers for reporting cases and ensuring high adherence to the treatments.
- Provide Direct Benefit Transfers to patients for acquiring the critical nutrition needed during treatment.
- Strengthen 'Nikshay program', which is a web-based TB case monitoring system introduced by the GOI.
Ministry of Electronics and Information Technology signed MOU with AYUSH3
On June 30, 2019, an MoU was signed between Ministry of AYUSH (MOA) and Ministry of Electronics and Information Technology (MeitY) for the digitization of AYUSH Sector. According to this MoU, MeitY will provide technical support to MOA for planning and development of AYUSH GRID Project. AYUSH, in pursuance to the National Health Policy 2017 and e-governance initiative, aims to digitize the entire field of health care delivery at all levels, and also for more significant research, education, delivery of various healthcare programmes and better drug regulations. Overall the MOU will help AYUSH to get the high quality technical support from MeitY for digitalization of AYUSH Ministry.
CCMB and CDFD collaborate to address the Genetic Disease burden of the Indian population4
On July 03, 2019, an MoU was signed between Centre for Cellular and Molecular Biology (CCMB) and Centre for DNA Fingerprinting and Diagnostics (CDFD); both are premier national institutes of CSIR involved in the cutting-edge biological research in the field of Genetics with rapid advancements in technology. Genetic disorders form a major group of the non-communicable diseases and third most frequent cause of mortality in neonates in the country. It is estimated that almost half a million babies are born with genetic diseases every year. The burden of these disorders is a threat for the society, as most of these disorders are presently untreatable and those which are treatable are very expensive. The preventive approach is the only available option to manage these disorders, which requires prenatal diagnosis and genetic counselling.
The MoU aims to maximize the potential of both the institutes in human disease diagnostics via quality DNA based diagnostic services to the public at lower costs, to develop newer diagnostic methods and to engage in scientific research to improve understanding of human genetic disorders. It also aims to conduct training and educational activities on Genetic Diagnostics in both the institutes.
Cabinet approves MoU between India and Maldives in the Health Sector5
On July 03, 2019, the Union Cabinet has given ex-post-facto approval to the Memorandum of Understanding (MoU) between the Government of India and the Government of the Republic of Maldives on cooperation in the field of Health signed on June 08, 2019. The MoU covers the following areas of cooperation - Exchange & Training of medical doctors, officials, other health professionals and experts, Medical and health research development, Regulation of medicines and medical products and exchange of information thereon, Communicable and Non-Communicable diseases, E-Health and Telemedicine and any other area of cooperation as may be mutually decided upon.
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