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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, 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.

1. India’s Trade and Economic Partnership Agreement (TEPA) with the European Free Trade Association (EFTA), effective October 1, 2025, reportedly excludes medical devices and pharmaceuticals from duty concessions, keeping them protected to safeguard domestic industries. While 92.2% of EFTA and 82.7% of India’s tariff lines are liberalised, sensitive healthcare products will face phased tariff reductions over 5–10 years.
Source: https://short-url.org/1hoSo

2. Central drug regulator (CDSCO) is reportedly set to conduct nationwide inspections and audits of cough syrup manufacturing units after child deaths in Madhya Pradesh were linked to toxic syrups. States and union territories have been directed to submit lists of manufacturers for surveillance, aiming to strengthen quality control and prevent contamination-related tragedies.
Source: https://short-url.org/1cGQR

3. Department of Pharmaceuticals has launched sensitisation programmes to guide pharmaceutical and medical technology companies on the amended Promotion of Research and Innovation in Pharma-MedTech Sector scheme. The sessions will help companies to understand the revised guidelines, and digital application process to ensure smooth participation.
Source: https://short-url.org/1cGR3

4. India’s Central food authority has issued a draft amendment to Packaging regulations 2018 to restrict the use of Poly- and perfluoroalkyl substances (PFAs) in food contact materials. It also states that food materials made with polycarbonate and epoxy resins must be free from Bisphenol A (BPA) and its derivatives. Objections / suggestions are awaited from the industry stakeholders for a period of 60 days from the date of publication.
Source: https://short-url.org/1hoTb

5. State drug inspectors are reportedly seeking enforceable powers to arrest and detain offenders, aiming to curb the growing menace of spurious drugs. The demand follows the recent incident involving contaminated cough syrup sold to paediatric patients, which resulted in multiple child deaths.
Source: https://short-url.org/1hoTt

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, 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.

1. The Supreme Court of India has ruled that only the Central Government can regulate, prohibit, or restrict the sale of drugs. The judgment clarifies that drug inspectors and regulatory authorities cannot impose such bans or unilaterally declare a medicinal product as prohibited without a central notification.
Source: bit.ly/3DTt3Su

2. The Food Safety and Standards Authority of India (FSSAI) has reiterated the compliance requirements for e-commerce Food Business Operators (FBOs). They warned against operating without a valid FSSAI license or registration and making unsupported claims online. FBOs have been urged to adopt practices ensuring a minimum shelf life of 30% or 45 days before expiry at the time of delivery to the consumer, and to strictly adhere to food safety standards.
Source: bit.ly/3Z9lzmA

3. Indian Micro, Small, and Medium Enterprises (MSMEs) in the pharmaceutical sector are seeking a 3-year, condition-free extension for implementing Schedule M. They have cited financial constraints in upgrading their manufacturing sites to comply with Schedule M standards. In this context, they urge the Indian government to provide support in the form of financial and technical assistance to improve quality standards. The health ministry recently issued a draft notification proposing to extend the deadline for MSMEs to comply with revised Schedule M norms from 31st December 2024, to 31st December 2025.
Source: bit.ly/4fPf8u0

4. The National Pharmaceutical Pricing Authority (NPPA) has revised the ceiling price of azithromycin 250 mg tablets to ₹11.67 per tablet, up from ₹11.65, following a review order by the Department of Pharmaceuticals (DoP). The review addressed Cipla Ltd.’s claim that its product, Azee 250 mg tablets, with a 2.3% market share, was omitted from the initial pricing calculation. The NPPA identified discrepancies in the Pharmatrac database and included Cipla’s product in the updated price.
Source: bit.ly/40kDNB8

5. Maharashtra police has arrested a man who was allegedly running an illegal call center that sold controlled medicines, like Viagra and Tramadol, to U.S. citizens. The accused used VOIP technology to impersonate a legitimate pharmaceutical representative. Authorities have seized several gadgets and accessories from the call centre and charged the individual under various laws, including the Information Technology Act and the Indian Telegraph Act.
Source: bit.ly/405X1Kw