NPPA revises the ceiling price of 6 scheduled formulations under Drugs (Prices Control) Order, 2013.
As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.
MoHFW notifies Drugs Draft Amendment Rules, 2021.
If the person proposing to manufacture a drug for the purpose of examination, test or analysis does not hold a licence in Form 25 or Form 28 in respect of such drugs he shall, before commencing such manufacture, shall obtain a licence in Form 29.
MoHFW revises Guidelines for issuance of Statement of Need (SON) Certificate/ Exceptional Need Certificate (ENC)/ No Obligation to Return to India (NORI) Certificate.
As per the new guidelines, applications for extension of Statement of Need Certificate (SON) and Exceptional Need Certificate (ENC) to Indian Medical doctors shall be processed only by the Ministry of Health and Family Welfare.
Draft New Drugs and Clinical Trials (Amendment) Rules, 2021
The amendment has revised Form CT-03 in which Registration certificate of Ethics Committee related to biomedical and health research shall be granted. The amendment provides that the registration may be granted by any Designated Registration Authority and not Central Licensing Authority.
CDSCO classifies medical device pertaining to dermatological and plastic surgery.
The medical devices are classified into risk classes of A, B and C based on the intended use, risk associated with device and other parameters as specified under the medical device rules 2017.
CDSCO evaluates certain pre 1988 permitted FDCs for manufacture for sale in the country.
Some of the popular brands that will come under latest review include piramal enterprises, saridon, abbott’s, phensedyl and tixylix, griffon’s Grilinctus, Cofdex, Nocold and Bromoli, Intas’ Despol and Reckitt Benckiser’s D-Cold, among others.
CDSCO classifies medical devices pertaining to Intervention Radiology.
CDSCO has classified 66 interventional radiology devices based on the intended use, risk associated with device and other parameters as specified under the medical device rules 2017.
CDSCO classifies medical devices pertaining to Cardiovascular under the provisions of Medical Device Rules, 2017.
The medical devices are classified based on the intended use, risk associated with the device, and other parameters specified in the first schedule of the Medical Devices Rules, 2017.
In-vitro Diagnostic Medical Devices classified based on the intended use and the risk involved
General intended use given against each In vitro Medical device is for guidance to the applicants who intends to furnish application of import or manufacture of medical devices under the provisions of Medical Devices Rules,2017. However, a device may have specified intended use as specified by its manufacturer.
Initiatives taken by the Health Ministry to Promote Indian Health care industry.
Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY) is a centrally sponsored scheme and it is an entitlement-based scheme. It provides financial risk protection against catastrophic health expenditure that impoverishes an estimated 6 crore people every year.
