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The Union Health Ministry has proposed mandatory installation of CCTV cameras at medical stores as part of amendments to the Drugs Rules, 1945, to strengthen oversight of the sale of prescription drugs. The proposed amendment seeks to prevent unauthorised access to and sale of Schedule H, H1 and X drugs without valid prescriptions. The ministry issued a draft Gazette notification, dated September 8, proposing the changes. The proposal was first deliberated by the Drugs Consultative Committee (DCC) and was subsequently circulated among members of the Drugs Technical Advisory Board (DTAB) for consideration. Following deliberation, the DTAB recommended approval of the proposal. The mandatory CCTV surveillance is being proposed as an additional regulatory safeguard to strengthen monitoring of the sale and distribution of Schedule H, H1 and X drugs at medical stores. The ministry said the measure is expected to help curb unauthorised sale and access to such medicines and improve ...
India has crossed 80 lakh human papillomavirus (HPV) vaccinations, marking another important milestone in strengthening preventive healthcare and protection against HPV infection and associated cancers, the Union health ministry said on Friday. The nationwide HPV vaccination campaign was launched on February 28 to vaccinate girls aged 14 years. The HPV vaccine plays a vital role in preventing cervical cancer, one of the most common cancers affecting women, it said. The single-dose Gardasil-4 vaccine is administered free of cost at government health facilities, including Ayushman Arogya Mandirs -- primary health centres (PHCs), community health centres (CHCs), sub-district and district hospitals and government medical colleges, the ministry said. Vaccinations are administered in the presence of medical officers, while vaccination sites are linked to 24x7 adverse events following immunisation (AEFI) management centres for prompt management of any adverse events, it said. Parental ...
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
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 ...
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, .
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
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.