Drugs Rules 1945

November 5, 2026 12:36 PM

Centre Proposes Immediate Suspension of Manufacturing Licences for Substandard Drugs

The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to allow immediate suspension of manufacturing licences for drugs found to be Not of Standard Quality (NSQ) on specified critical quality parameters. The proposed changes aim to strengthen regulatory oversight, ensure prompt action against substandard medicines and prevent their continued manufacture and distribution to safeguard public health. Under the existing provisions, suspension or cancella...

November 4, 2026 12:05 PM

Centre proposes amendments to drugs rules to ensure qualified personnel authorise drug batch release

The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to make it mandatory for drug manufacturers to formally authorise qualified and experienced personnel for the release of drug batches. The proposed amendments aim to strengthen accountability, improve documentation and enhance quality assurance in pharmaceutical manufacturing by clearly identifying the personnel responsible for approving drug batches before they are released for distribution. Unde...

November 3, 2026 11:26 AM

Centre proposes expansion of import gateways for drugs, medical devices and cosmetics

The Union Ministry of Health and Family Welfare has proposed expanding the network of authorised import gateways for drugs, medical devices and cosmetics by adding several Inland Container Depots (ICDs), a Special Economic Zone (SEZ) and an international airport to the existing list. The proposed amendment to Rule 43A of the Drugs Rules, 1945, aims to streamline import procedures, improve logistics efficiency and facilitate the timely movement of healthcare products across the country. Under t...

October 9, 2026 12:53 PM

Health Ministry Proposes Tighter Curbs on Advertising of Prescription Medicines

The Union Ministry of Health and Family Welfare has proposed stricter regulations on the advertising of prescription medicines by extending existing restrictions to retailers, wholesalers and distributors. The proposed amendment to the Drugs Rules, 1945, seeks to make prior approval of the Central Government mandatory for advertisements relating to medicines listed under Schedule H, Schedule H1 and Schedule X. The draft amendment has been notified through Gazette Notification G.S.R. 86...

June 16, 2026 4:43 PM

Centre tightens regulation of cough syrup sales, withdraws exemption for small villages

In a move aimed at strengthening regulatory oversight and ensuring safer distribution of medicines, the Ministry of Health and Family Welfare (MoHFW) has amended the Drugs Rules, 1945, withdrawing a long-standing exemption that allowed the sale of cough syrups in small villages without compliance with certain retail licensing requirements. The amendment, notified through Gazette Notification G.S.R. 927(E) dated December 29, 2025, removes the word "Syrup" from Schedule K, Serial No. 13, Entry 7 ...