Health Ministry

Prescription, licence must to sell drugs with high-alcohol content

Oral drug formulations containing over 12 per cent ethyl alcohol will require prescriptions and licensed retail sale under new rules aimed at curbing misuse and hoarding

Centre amends drug rules to curb misuse of high-alcohol formulations

The Centre said it has removed the Schedule K exemption for medicinal formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 mL

Health Ministry notifies Navi Mumbai Airport as port for import of drugs

The Union health ministry has recently inaugurated Navi Mumbai Airport in Maharashtra as a port for the import of drugs under the Drugs Rules, 1945, in a move aimed at strengthening the pharmaceutical supply chain and facilitating ease of trade, an official statement said on Wednesday. The amendment to Rule 43A of the Drugs Rules, 1945, now includes Navi Mumbai in the list of airports through which drugs may be imported into the country, according to the statement issued by the ministry. The gazette notification was issued after consultation with the Drugs Technical Advisory Board under the provisions of the Drugs and Cosmetics Act, 1940, officials said. With the latest addition, the total number of notified ports of entry -- across air, sea, road and rail -- for the import of drugs has increased to 42, it said. The amendment is expected to facilitate smoother movement of pharmaceutical consignments, strengthen logistics infrastructure, and provide greater flexibility to importers

Centre proposes easing shelf-life, licensing norms for imported drugs

Draft amendments propose a 12-month minimum residual shelf life for imported drugs and an acknowledgement-based mechanism for importing medicines for research

Govt proposes mandatory one-year residual shelf life for imported drugs

The Union Health Ministry has published a draft notification proposing amendments to the drugs rules under which imported drugs should have a minimum residual shelf life of 12 months at the time of import. The step would ensure that patients receive medicines with adequate usable shelf life and improve utilisation of pharmaceutical inventories across the supply chain. The draft amendment published for public consultation vide gazette notification on June 22 proposes to revise the existing requirement of a minimum residual shelf life of more than 60 per cent for imported drugs to a minimum residual shelf life of 12 months at the time of import. However, in view of their specialised nature and public health considerations, the existing requirement of a minimum residual shelf life of more than 60 per cent shall continue to apply to biological products and radiopharmaceuticals. The proposed amendment seeks to facilitate greater efficiency in the pharmaceutical supply chain while ...

Govt mandates QR codes for vaccines, antimicrobials and cancer drugs

The government has expanded the ambit of the QR code-based track-and-trace mechanism to cover all antimicrobials, vaccines, anti-cancer medicines, and narcotic and psychotropic drugs, a move aimed at strengthening safeguards against counterfeit and substandard medicines. The Union Health Ministry has notified amendments to the Drugs Rules, 1945, bringing these categories of medicines under Schedule H2, which mandates the use of bar codes or Quick Response (QR) codes for product identification and verification. Under the amended provisions, manufacturers will be required to print or affix a barcode or QR code on the primary packaging label of the drug formulation, or on the secondary packaging where space constraints exist, the ministry said. The code will enable authentication and verification of medicines through software applications across the supply chain. According to the ministry, the QR code will contain key product information such as a unique product identification code, .

Centre mandates periodic renewal of IVF, ART and surrogacy clinics

Centre mandates periodic renewal of registrations for ART and surrogacy clinics to strengthen oversight, improve compliance, and boost patient confidence

Government bans 16 fixed drug combinations over health safety concerns

Health Ministry prohibits 16 fixed drug combinations, including antibiotic and cosmetic formulations, after an expert review found they lacked therapeutic justification and posed potential health risk

Centre bans sale, manufacture of 16 FDC drugs over public health concerns

The Centre has prohibited the manufacture, sale and distribution of 16 fixed-dose combination (FDC) drugs, saying they lack "therapeutic justification" and their continued use was not considered beneficial in relation to the potential risks involved. The move, the Union Health Ministry said, was to safeguard public health and promote rational use of medicines while ensuring only effective and scientifically validated medicines are available to the public. FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio. The decision follows a review of FDCs undertaken in compliance with the Supreme Court's directions. The Drugs Technical Advisory Board (DTAB) had constituted an expert committee to examine various drug combinations and identify those that were irrational, therapeutically unjustified or potentially harmful. "The manufacture for sale, sale, distribution and supply of the identified 16 FDCs for human use shall sta

Govt's cough syrup move may shift rural demand towards Ayush remedies

The removal of cough syrups from Schedule K could make access more prescription-dependent in rural India, potentially shifting some demand towards Ayush products

Kerala records 70 Shigella cases, 4 deaths in June: Health minister

Kerala Health Minister K Muraleedharan on Tuesday said that since January this year, 146 cases of Shigella were reported in the state and of those 70 were in June. Speaking to reporters here after chairing a review meeting, Muraleedharan said that of the five Shigella deaths, one was in March and the remaining four were in June. The highest number of cases -- 74 -- of the bacterial infection from January to June were reported from Kozhikode, followed by Malappuram -- 25, including two deaths -- and then Thiruvananthapuram -- also 25 cases of infection, according to the figures given by the minister. No Shigella cases were reported from Pathanamthitta, Palakkad and Kasaragod districts of the state till now this year, he said. Shigella is a bacterial infection that causes diarrhoea, fever and stomach cramps. It spreads mainly through contaminated food or water and through contact with infected persons.

Households' out-of-pocket expenditure on health care rose in FY23

Household spending drops from 64 percent over a decade amid rise in public health expenditure

CDSCO flags spurious liver drug, 169 others fail quality tests in April

CDSCO flags one batch of a liver drug as spurious and identifies 169 drugs and formulations as not of standard quality during April surveillance

Union Health ministry brings pregabalin under Schedule H1 to prevent misuse

The Union Health Ministry has brought pregabalin, a drug used for treating chronic pain and certain neurological conditions, under the stricter Schedule H1 category amid reports of its misuse and abuse. The ministry notified the inclusion of pregabalin under Schedule H1 of the Drugs Rules, 1945, through a gazette notification on May 20. "The decision has been taken in view of reports received from certain states regarding the misuse and abuse of Pregabalin, particularly among youth," the ministry said. The drug, which is prescribed for the treatment of chronic pain, neuropathies, fibromyalgia, and certain neurological conditions, has reportedly been misused for its sedative, euphoric, and dissociative effects. The ministry cited seizures of illegal stocks and sales of pregabalin in parts of the country. The medicine was earlier regulated under Schedule H under the Drugs and Cosmetics Rules, 1945. Under the revised classification, the drug can now be sold only against a valid ...

Health Ministry activates precautionary surveillance amid hantavirus

The Health Ministry has stepped up surveillance after probable hantavirus cases were reported onboard the cruise ship MV Hondius, with two Indians under observation

Digital platform launched to strengthen maternal, child healthcare services

The Union Health Ministry has launched a digital platform aimed at strengthening maternal and child healthcare services through seamless tracking of beneficiaries, real-time monitoring and interoperable health records. Launched during the national summit on Innovation and Inclusivity Best Practices Shaping India's Health Future, JANANI (Journey of Antenatal, Natal and Neonatal Integrated Care) is a service-oriented digital platform designed to comprehensively monitor and maintain digital health records of women during their reproductive years, a health ministry statement. Developed as an upgraded version of the existing Reproductive and Child Health (RCH) portal, the platform creates a longitudinal health record by capturing service delivery events across the continuum of care, the statement said. JANANI will facilitate continuous tracking of maternal and child healthcare services, including antenatal care, delivery preparedness, institutional delivery, postnatal care, newborn care,

Centre revises DCGI recruitment rules, raises age limit to widen pool

The Centre has raised the age limit and broadened eligibility norms for appointing the Drug Controller General of India to address a shortage of qualified candidates

Parliamentary panel pulls up HealthMin over drug scheme funding gaps

Panel flags funding discontinuity in drug regulation scheme, urges swift SSDRS 2.0 approval and decentralisation of medical device clearances to ease bottlenecks and improve oversight

Medtech industry split over Centre's move on standard device testing fees

Medtech firms are split over draft norms on standardised testing fees, with some backing transparency and others warning of higher compliance burden for low-risk devices

Govt intensifies checks on illegal sale, misuse of GLP-1 weight-loss drugs

As cheaper GLP-1 weight-loss drugs flood India after patent expiry, the government has intensified surveillance to curb illegal sales, misleading promotion, and unsafe use without medical supervision