BIS Sets New Standards for Ayush Sector
The Bureau of Indian Standards (BIS) has taken a step towards ensuring quality and safety in the Ayush sector by establishing a dedicated standardization department. This move aims to bolster the credibility and reach of traditional Indian medicine systems like Ayurveda, Yoga, Naturopathy, Unani, Siddha, Sowa-Rigpa, and Homoeopathy.
AYUSH Ministry Cracks Down Against Misleading Advertisements
The government is leveraging various legal frameworks, including the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, to take action against defaulters. Additionally, the Press Council of India has been actively involved in addressing misleading advertisements in print media.
Hikes In Ceiling Prices For Scheduled Formulations
The National Pharmaceutical Pricing Authority (NPPA) has issued a notification revising the ceiling prices for scheduled formulations. This action aims to regulate drug prices in the country and it takes into consideration the Wholesale Price Index (WPI) impact @0.00551% for the year 2024. These notifications were issued on August 7, 2024.
NPPA Revises Retail Prices for 70 New Drug Formulations
The National Pharmaceutical Pricing Authority (NPPA) has fixed the retail prices for 58 + 12 pharmaceutical formulations. These prices are exclusive of Goods and Services Tax, if applicable. These prices were notified on August 6, 2024.
India Exempts Local Clinical Trials For New Foreign Drugs
The Indian government has announced a streamlined approval process for certain categories of new drugs recognizing approvals from key global regulatory authorities. CDSCO has specified a waiver from local clinical trials for USA, UK, Japan, Australia, Canada, and the European Union (EU).
CDSCO Urges Manufacturers To Implement New Drug Manufacturing Rules
The guidelines outline several key principles to be adhered to by pharmaceutical manufacturers, focusing on pharmaceutical quality systems, quality risk management, sanitation and hygiene, qualification and validation, complaints and adverse reactions, product recalls, and change control. The CDSCO has also advocated for manufacturers to comply particularly with WHO good manufacturing practices for sterile pharmaceutical products.
NOTTO Publishes Organ Transport SOPs – 2024
The National Organ & Tissue Transplant Organization (NOTTO) of the Ministry of Health and Family Welfare (MOHFW) has released new Standard Operating Procedures (SOPs) to streamline and expedite the transport of live human organs across the country. The SOPs aim to ensure the safe and efficient transfer of organs for transplantation.
Draft Western Ghats Ecologically Sensitive Area (ESA) Notified
Several activities will be prohibited or regulated within the ESA, including mining, expansion of existing polluting industries, and large-scale construction projects. Existing mining operations will be phased out within five years. However, existing healthcare facilities and repair/extension of residential houses are exempted.
New Insights into DPCO, 2013 and NPPA Oversight
The DPCO, 2013, is a cornerstone in India’s pharmaceutical regulation, balancing the interests of manufacturers and consumers by ensuring fair drug pricing. Through annual revisions, strict GMP compliance, and vigilant monitoring, the NPPA ensures that medications remain affordable and accessible, reflecting the government’s commitment to public health.
Relaxing Norms for Toxicity Studies in Drug Approval
The CDSCO aims to streamline the drug approval process without compromising safety. The New Drugs and Clinical Trials Rules, 2019 allow for the acceptance of preclinical toxicity data generated in other countries, provided the data is of high quality and meets specified standards.
