Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
New marketing code for pharmaceutical companies notified; Pharmaceutical Associations to set up dedicated portal for handling complaints of violations
The Department of Pharmaceuticals has notified Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024. In order to ensure strict compliance with UCPMP, all pharmaceutical associations are required to establish an Ethics Committee for Pharmaceutical Marketing Practices (ECPMP) and set up a dedicated UCPMP portal on their websites. Unlike the previous iteration of the code, the 2024 iteration has explicitly permitted pharma and medical device companies to provide brand reminders up to Rs. 1000 per item, and has also allowed another informational and educational items to be included in the category of brand reminders.
Source: bit.ly/3IClT44
New law for regulation of prices of Drugs and Medical Devices soon; Indian Government constitutes a high level committee
India’s Department of Pharmaceuticals has constituted a committee which has been tasked to draft a new Drugs and Medical Devices (Control) Order. The committee will also examine pricing regulation for drugs and medical devices with focus on balancing price availability for essential medicines and price moderation for medical devices without hindering growth of industry.
Source: bit.ly/3v8Nff5
Government can give precedence to quality over price in tenders of life saving medical devices: High Court
The High Court of Jharkhand in India, while deciding on the validity of decision rendered by Tender Committee for medical devices, has stressed that pricing cannot be the sole criteria for awarding tender, and the Tender Committee was within its right to consider quality of the medical devices in addition to pricing. The Court observed that judgments made by expert committees must not be subject to scrutiny by courts and in cases involving tenders, the focus should solely be on the decision-making process rather than the perceived validity of the decision itself.
Source: bit.ly/3ICmNOi
Export of human blood and human blood components samples will require NOC from Drugs Regulator or Indian Council of Medical Research
India’s Ministry of Commerce has amended its export policy put restrictions on export of samples of human blood and biologicals such as anti-sera made from human blood. If the purpose of export of sample relates to its use in development of a drug, then a NOC from Central Drugs Control Organization (CDSCO) will be required. In all other cases, a NOC from Indian Council of Medical Research (ICMR) will be required.
Source: bit.ly/3VbtuhG
Anti-trust Committee recommends law to regulate conduct of large digital enterprises
The Committee of Digital Competition Law has recommended that the Indian Government should proactively regulate behaviour of large digital enterprises, and that the Competition Commission of India (CCI) should intervene before instances of anti-competitive conduct transpire. At present, CCI has powers to intervene after anti-competitive conduct has been committed. Large digital enterprises are enterprises which have significant presence and financial strength, and provide core digital services.
Source: bit.ly/3PokH8j