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.
Inclusion Of Homoeopathic And Sowa-Rigpa Systems Authoritative Books In Drugs and Cosmetics Act
The Central Government, in consultation with the Ayurveda, Siddha, Unani Drugs Technical Advisory Board, has introduced an amendment to the Drugs and Cosmetics Act, 1940. The amendment aims to modify the First and Second Schedules of the Act. This amendment was published on December 9, 2024.
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.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For October 2024
The NSQ drug list specifies a total of 34 drugs that were detected to be deficient by State Lab Drugs Control Laboratories. The NSQ drug list for central CDSCO laboratories specifies a total of 56 drugs that were detected to be deficient. Additionally, CDSCO has also identified 3 drugs to be spurious.
Drugs (Fifth Amendment) Rules, 2024
The Drugs (Fifth Amendment) Rules, 2024 has introduced changes to the licensing and manufacturing processes for Ayurveda, Siddha, Sowa-Rigpa, Unani, Homeopathic medicines in India. The rules introduce online applications through the e-AUSHADHI portal for selling, stocking, and distributing Homoeopathic medicines. It has standardize fees for license applications.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For September 2024
The NSQ drug list specifies a total of 18 drugs that were detected to be deficient by State Lab Drugs Control Laboratories. All of these 18 drugs were declared to be not of standard quality. The NSQ drug list for central CDSCO laboratories specifies a total of 49 drugs that were detected to be deficient. Additionally, CDSCO has also identified 4 drugs to be spurious.
CDSCO Requires Registration Of Clinical Research Organizations
The Central Drugs Standard Control Organization (CDSCO) has announced amendments to the New Drugs and Clinical Trials Rules, 2019. These amendments aim to strengthen the regulatory framework for clinical research organizations (CROs) in India. CROs are now required to register with the Central Licensing Authority before conducting clinical trials.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For August 2024
The NSQ drug list specifies a total of 11 drugs that were detected to be deficient by State Lab Drugs Control Laboratory, Telangana. All of these 11 drugs were declared to be not of standard quality. The NSQ drug list for central CDSCO laboratories specifies a total of 48 drugs that were detected to be deficient. Additionally, CDSCO has also identified 5 drugs to be spurious.
Vaccine Samples Declared Not of Standard Quality 2017-2023
The Central Drugs Standard Control Organization (CDSCO) has released a report detailing various instances of substandard vaccines identified in India over the past six years, i.e. from 2017-2023. The report identified substandard vaccines across various categories, including typhoid, tetanus, polio, and COVID-19 vaccines.
Online Applications Now Mandatory for New Veterinary Drug Permissions and Field Trials
The Central Drugs Standard Control Organization (CDSCO) has announced a shift to online applications for all new drug permissions and field trials related to veterinary medicine. All new applications for new drug permissions and field trials concerning veterinary products must be submitted electronically through the SUGAM Portal.
