India Updates Drug and Healthcare Regulations, August 2024
核心洞察
The Drugs Controller General of India (DCGI) has waived clinical trial requirements for specific drug categories approved in certain countries.
The CDSCO (搜索) has mandated manufacturers to comply with revised Schedule M and WHO Technical Report Series guidelines for pharmaceutical products.
The Ministry of Health and Family Welfare banned 156 fixed-dose combination drugs due to potential risks to human health.
The month of August 2024 saw significant developments in India's pharmaceutical and healthcare sectors, marked by regulatory updates, government initiatives, and key judgments. These changes aim to enhance drug safety, streamline processes, and improve healthcare accessibility.
Clinical Trial Waivers for Approved Drugs
The DCGI announced on August 7, 2024, a waiver from the requirement of clinical trials in India for drugs already approved in the United States, United Kingdom, Japan, Australia, Canada, and the European Union. This applies to Orphan Drugs for Rare Diseases, Gene and Cellular Therapy Products, New Drugs used in Pandemic Situations, New Drugs for Special Defense Purposes, and New Drugs with significant therapeutic advances, aligning with Rule 101 of the New Drugs and Clinical Trial Rules, 2019.
Compliance with Manufacturing Standards
On the same day, the Central Drugs Standard Control Organization (CDSCO (搜索)) mandated that all manufacturers must comply with the revised Schedule M and various World Health Organization (WHO) Technical Report Series (TRS) guidelines. This includes WHO TRS 1044 Annexure-2, focusing on good manufacturing practices for sterile pharmaceutical products.
Draft Guidelines on Good Distribution Practices
CDSCO (搜索) released draft guidelines on Good Distribution Practices for Pharmaceutical Products on August 9, 2024, aligning with WHO TRS on Good Storage and Distribution practices. These guidelines aim to prevent the introduction of spurious, adulterated, or substandard pharmaceutical products into the market. The draft was published for public consultation for 30 days.
Restrictions on Cosmetics Products Per Application
To streamline registration and import of cosmetics, the CDSCO (搜索) has limited the number of products to a maximum of 50 per online application via the SUGAM portal, effective August 16, 2024. This change is intended to expedite application processing within the timelines set by the Cosmetics Rules, 2020.
Ban on Fixed-Dose Combination Drugs
The Ministry of Health and Family Welfare banned 156 fixed-dose combination (FDC) medications on August 2, 2024, due to safety concerns. These "cocktail drugs," including multivitamins, antibiotics, and painkillers, were deemed to pose risks to human health, with safer alternatives available. The manufacture, sale, or distribution of these FDCs is now prohibited.
Launch of ADRMS Online Portal
An online Adverse Drug Monitoring System (ADRMS) software, developed indigenously under the Pharmacovigilance Programme of India (PvPI), was launched on August 19, 2024. This system facilitates the reporting of adverse events related to medicines and medical devices by patients, caregivers, and healthcare professionals, and allows Indian Pharmaceutical Industries/Marketing Authorizations Holders (MAHs) to report adverse events directly.
Indian Pharmacopoeia Online Portal
The Indian Pharmacopoeia (IP) Online Portal (www.iponline.ipc.gov.in) was launched on August 19, 2024, to enhance accessibility to IP standards. This allows users to refer to drug monographs on computers and mobile devices, extending the reach of the IP to a broader audience.
NPPA Recommends Retail Prices for Anti-Diabetes Combinations
The National Pharmaceutical Pricing Authority's (NPPA) Multidisciplinary Committee (MDC) has recommended retail prices for anti-diabetes (搜索) drug combinations involving empagliflozin. This move aims to increase affordability for diabetic patients as the drug is expected to go off-patent in March 2025.
Dengue Vaccine Phase 3 Clinical Trial
The Indian Council of Medical Research (ICMR) and Panacea Biotech (搜索) initiated the first Phase 3 clinical trial for a dengue (搜索) vaccine in India. The trial will evaluate the efficacy of DengiAll, an indigenous tetravalent dengue vaccine developed by Panacea Biotech. The first participant was vaccinated on August 14, 2024, at PGIMS, Rohtak.
BioE3 Policy Approved
The Union Cabinet approved the 'BioE3 (Biotechnology for Economy, Environment and Employment) Policy for Fostering High Performance Biomanufacturing' on August 24, 2024. This policy aims to support R&D and entrepreneurship, accelerate technology development, and promote a circular bioeconomy.
Veterinary Treatment Guidelines Workshop
A workshop on 'Finalization of Standard Veterinary Treatment Guidelines' (SVTG) was organized by the Food and Agriculture Organization (FAO) from August 8-9, 2024. These guidelines aim to provide a framework for Animal Health Practitioners, ensuring consistency in prescription practices and enhancing compliance.
Extension for Feedback on Packaged Commodities Rules
The Department of Consumer Affairs extended the deadline to August 30, 2024, for submitting comments on proposed changes to Rule 3 of the Legal Metrology (Packaged Commodities) Rules, 2011. The amendment mandates the declaration of all information on pre-packaged commodities meant for retail sale.
Safety Policies for Medical Colleges
The National Medical Commission (NMC) advised medical colleges to implement comprehensive safety policies for staff and students, ensuring safe workplace environments and prompt investigation of violence incidents.
Illegal Imports of Chlorinated Gloves
The Ministry of Environment flagged the continued import of banned chlorinated gloves, seeking compliance status from the DCGI and BIS. These gloves, often used in healthcare, pose environmental risks and violate existing standards.
FSSAI Extends Deadline for Fruit Juice Claims
The Food Safety and Standards Authority of India (FSSAI) extended the deadline to December 31, 2024, for utilizing pre-printed packaging materials with the claim '100% fruit juice' on labels and advertisements for reconstituted fruit juices.
A1 and A2 Milk Products Advisory
The FSSAI issued an advisory on August 21, 2024, stating that the use of A2 claims on milk fat products is misleading. However, this advisory was withdrawn on August 26, 2024, for further consultation.
National Medical Register Portal Launched
The National Medical Register (NMR) Portal of the NMC was launched on August 23, 2024, for the registration of all MBBS doctors eligible for registration in India. This database aims to streamline the registration process and improve healthcare quality.
Supreme Court Orders Establishment of National Commission
The Supreme Court ordered the Union and State Governments to establish the National Commission and State Councils under the National Commission for Allied and Healthcare Professions Act, 2021, within two months.
Supreme Court Stays AYUSH Ministry's Notification
The Supreme Court stayed the AYUSH Ministry's July 1, 2024, notification omitting Rule 170 of the Drugs and Cosmetics Rules, 1945, which prohibits misleading advertisements of Ayurvedic, Siddha, and Unani medicines.
Complaints of Misleading Advertisements
The Ministry of AYUSH has received 38,539 complaints of misleading advertisements related to Ayurveda, Siddha, Unani, and Homoeopathy (ASU&H) products.
Bhang Declared as Intoxicant
The Odisha government classified 'Bhang' as an intoxicant on August 12, 2024, due to its potential to cause various symptoms.
Discount Pharmacies to Display Price Lists
The Drug Control Administration in Kerala directed all discount pharmacies to display a list of items with applicable discounts, following an order from the Kerala High Court.
WHO Encourages Early Discussions for Mpox Vaccine Purchases
The World Health Organization (WHO) announced that partners can begin commercial discussions to procure Mpox (搜索) (monkeypox) vaccines even before formal regulatory approval is granted.
PMSMA Strategy Launched
The Government of India launched the 'Pradhan Mantri Surakshit Matritva Abhiyan' (PMSMA) strategy to ensure quality antenatal care to pregnant women.
Key Judgment: Prashant S/o Gokul Tipale vs State of Maharashtra
The Nagpur Bench of Bombay High Court quashed a criminal case against a psychiatrist for selling medicines to patients, provided they comply with the Drug and Cosmetics Act, 1940, and its rules. This judgment protects doctors from prosecution for selling medicines to their patients provided they comply with the Drug and Cosmetics Act, 1940 (Act)and its rules.