India’s Pharmaceutical Industry With Ambitious Growth Plans
India’s pharmaceutical industry is a significant force in the global market, boasting a strong domestic presence and a rapidly growing export sector. National Institutes of Pharmaceutical Education & Research (NIPERs) spearhead research efforts.
Government Ramps Up Production of Pharmaceuticals and Medical Devices in India
The PLI scheme for Bulk Drugs, with a financial outlay of Rs. 6,940 crore, incentivizes the manufacturing of essential Key Starting Materials (KSMs), Drug Intermediates (DIs), and Active Pharmaceutical Ingredients (APIs). With a budget of Rs. 15,000 crore, the PLI Scheme for Pharmaceuticals focuses on high-value products like patented/off-patented drugs, biopharmaceuticals, complex generics, and anti-cancer drugs. The PLI Scheme for Promoting Domestic Manufacturing of Medical Devices targets high-end medical devices previously imported into India.
NPPA Extends Ceiling Prices for Orthopaedic Knee Implants
The NPPA has decided to continue the current ceiling prices for primary and secondary knee replacement systems. The specific ceiling prices for primary and secondary knee replacement systems will remain unchanged for another year, i.e. from September 16, 2024 to September 15, 2025, or until the next revision.
Government Seeks Public Feedback on Drug Distribution Practices
The Central Drugs Standard Organisation (CDSCO) is seeking public feedback on draft guidelines for Good Distribution Practices (GDP) for pharmaceutical products. These guidelines aim to ensure proper storage and handling of medicines throughout the supply chain, from manufacturers to retailers.
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 54 New Drug Formulations
The retail price for these specified formulations must match the specified price. Manufacturers are required to submit a price list in Form–V via IPDMS to the National Pharmaceutical Pricing Authority (NPPA) and provide copies to State Drug Controllers and dealers. Retailers and dealers must clearly display the price list provided by manufacturers to ensure it is easily accessible to customers.
NPPA Calls For Data On Essential IV Fluids In India
The National Pharmaceutical Pricing Authority (NPPA) has issued an office memorandum regarding data submission of Price To Retailer (PTR) and Moving Annual Turnover (MAT) values for October 2023 for each specified IV fluid formulation. The information must be submitted by June 15, 2024.
NPPA Updates Data Requirements for Fixing Drug Prices in India
The National Pharmaceutical Pricing Authority (NPPA) has issued a new office memorandum regarding data submission of Price To Retailer (PTR) and Moving Annual Turnover (MAT) values for October 2023. The information must be submitted within 10 days of this notice, i.e. by June 15, 2024.
New NOC From CDSCO Zonal Offices Required for Export of Unapproved Or Banned Drugs
The Central Drugs Standard Control Organization (CDSCO) has announced a simplified process for obtaining No Objection Certificates (NOCs) for exporting unapproved, banned, or new drugs. Manufacturers shall obtain NOCs from CDSCO zonal offices through the online SUGAM portal (effective May 15th, 2024) before applying for a manufacturing license from state authorities.
Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS)
This initiative seeks to upgrade the technological capabilities of the Indian pharmaceutical industry, aligning it with global standards. The revised guidelines aim to support the pharmaceutical industry’s upgradation to the Revised Schedule-M & WHO-GMP standards, thereby enhancing the quality and safety of pharmaceutical products manufactured in the country.
