Latest news with #DepartmentofPharmaceuticals
Mint
a day ago
- Health
- Mint
India to introduce more advanced testing for imported blood products to reduce infection risk
New Delhi: The health ministry plans to mandate the use of a faster and more accurate method to test all imported blood products to maintain the highest safety standards and reduce the risk of infection from transfusions. The ministry intends to introduce nucleic acid testing (NAT) to improve the screening of imported blood products for antibodies of the human immunodeficiency virus (HIV), the hepatitis B virus, the hepatitis C virus and other impurities, an official aware of the matter said. The decision to shift to NAT has already been taken by the regulator, the Drug Controller General of India (DCGI), and the matter was discussed at the Drugs Technical Advisory Board meeting in April. The board is the highest statutory body responsible for advising the Central and state governments on technical matters related to the administration of the Drugs and Cosmetics Act, 1940. Also Read | Banking on blood: Health ministry frames guidelines to curb paid donations, improve efficacy of transfusions With the introduction of NAT, the conventional testing method known as ELISA, or enzyme-linked immunosorbent assay, will be done away with. ELISA, while a powerful tool, has several drawbacks, including the potential for false positive and negative results, apart from being time-consuming. The Department of Pharmaceuticals and the National Institute of Biologicals (NIB) in Noida had issued an alert in October after the NIB found three imported blood products—Berirab-P (used in rabies injections), Hepabig (to prevent hepatitis B virus infection) and Tetglob (used for tetanus treatment)—to be of sub-standard quality. When the Berirab-P and Hepabig samples were tested again at the National Institute of Virology in Pune using an advanced version of polymerase chain reaction, which is more sensitive than ELISA, they passed the test metrics. The set of Tetglob samples sent to a private laboratory that used ELISA were non-reactive. Safety standards Bharat Serums and Vaccines Ltd, now owned by Mankind Pharma, is the only company in the country that imports these lifesaving blood products. Imported blood products are used for the treatment of critically ill patients or those who are suffering thalassemia and other blood-related disorders. These products are tested at government laboratories to ensure they meet safety and quality standards. Also Read | India plans standard evaluation and quality protocols for HMPV' testing kits 'These are tested using conventional methods, but now the plan is to amend the rules to allow an advanced version of testing in line with international practices," the official said. 'NIB also proposed that an amendment may be considered to test blood products by NAT." Queries sent to the health ministry, the Department of Pharmaceuticals and the Mankind Pharma spokesperson remained unanswered till press time. 'NAT testing gives accurate and quick results and nowadays it is highly used. NAT testing is used for tuberculosis and NAT testing was modified during the covid-19 pandemic to detect the coronavirus," a scientist from the Indian Council of Medical Research said, requesting anonymity. 'The ELISA test may sometimes give false results if the viral load in the sample is low. However, PCR and NAT give accurate results even if the viral load is low." Also Read | ICMR and CDSCO develop framework for validation of pathogen identification and antimicrobial susceptibility testing According to an assessment by the National Blood Transfusion Council, the apex policymaking body for issues pertaining to blood and plasma, the clinical requirement of blood in the country is about 14.5 million units per year. The volume of each unit of blood is about 450 ml. In India, the import, manufacture, distribution and sale of drugs, cosmetics and notified medical devices are regulated by the Drugs and Cosmetics Act and the Drugs and Cosmetics Rules, 1945.
Hans India
7 days ago
- Business
- Hans India
Centre invites drugmakers to apply for PLI scheme aimed at boosting key medicines production
New Delhi: The Department of Pharmaceuticals has invited applications from drug manufacturers under the Production Linked Incentive (PLI) scheme to set up new manufacturing units for 11 key pharmaceutical products. This move aims to strengthen India's domestic drug production capabilities. The products include important antibiotics and painkillers such as Neomycin, Gentamycin, Erythromycin, Streptomycin, Tetracycline, Ciprofloxacin, and Diclofenac Sodium. These medicines are either unsubscribed or only partially subscribed under the earlier phases of the scheme. Manufacturers can submit their applications until June 14. The PLI scheme comes with certain conditions. Incentives will be provided based on available capacity, a defined ceiling for each product, and the production timeline. For chemical synthesis products, the incentive period will last until the financial year 2027-28, while for fermentation-based products, it will extend up to 2028-29. However, companies that were previously approved and later withdrew or had their approvals cancelled are not eligible to reapply. The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has encouraged its members to make the most of this opportunity. Pharmexcil Director General Raja Bhanu said the scheme offers a significant chance for companies to boost their manufacturing capacity in essential drug ingredients. This fresh call for applications is part of the government's ongoing push to promote domestic production of critical Key Starting Materials (KSMs), Drug Intermediates (DIs), and Active Pharmaceutical Ingredients (APIs). The PLI scheme for these categories was first introduced in 2020 and later revised to better suit the industry's needs. It covers a total of 41 products and has a financial outlay of Rs 6,940 crore. The initiative is part of a broader effort by the government, which launched PLI schemes for 14 major sectors four years ago. These include bulk drugs, medical devices, electronics, food processing and automobiles. According to official data, till November 2024, about 764 applications had been approved under these schemes, leading to an investment of Rs 1.61 lakh crore (around $18.7 billion). The government has disbursed Rs 14,020 crore in incentives so far under 10 sectors.
The Hindu
7 days ago
- Business
- The Hindu
PLI scheme for 11 pharma products rolled out
The Centre's Department of Pharmaceuticals is inviting applications from drugmakers for a production linked incentive (PLI) scheme to encourage setting up new manufacturing capacities for as many as 11 eligible products. Neomycin, Gentamycin, Erythromycin, Streptomycin, Tetracycline, Ciprofloxacin and Diclofenac Sodium figure in the list. These are either unsubscribed or partially subscribed eligible products, the Department said in a notification earlier this month. June 14 has been set as the last date for the manufacturers to submit the applications. Conditions such as allocation according to available capacities, incentive ceiling in respect of products, and limit of incentive up to the production tenure, which will be up to FY28 for chemical synthesis products and up to FY29 for fermentation-based products, have to be complied with. Companies that were granted approval earlier, but subsequently withdrew or whose approval was cancelled are not eligible to apply, it said. The Pharmaceuticals Export Promotion Council of India has urged its members to take advantage of the decision. The scheme presents a significant opportunity to enhance their manufacturing capabilities in critical pharmaceutical components, Pharmexcil Director General Raja Bhanu said. The Department of Pharmaceuticals' decision is in continuation of India's emphasis on encouraging domestic manufacturing of critical key starting materials, drug intermediates and active pharmaceutical ingredients. Four years ago the government had rolled out PLI schemes for 14 key sectors, which included bulk drugs, medical devices and pharma, with an eye on boosting production, generating jobs and boosting exports by incentivising domestic manufacturing. The scheme for KSMs, DIs and APIs, whose guidelines were issued in July 2020 and revised in October the same year, cover a total of 41 products and has a financial outlay of ₹6,940 crore, as per official documents. In March 2025, the government had announced that 764 applications have been approved under the schemes for the 14 key sectors and investment of around ₹1.61 lakh crore ($18.72 billion) reported till November 2024. Incentive of around ₹14,020 crore have been disbursed under the PLI schemes for 10 sectors, including large-scale electronics manufacturing (LSEM), IT hardware, bulk drugs, medical devices, pharmaceuticals, telecom and networking products, food processing, white goods, automobiles and auto components and drones and drone components.
Mint
11-05-2025
- Health
- Mint
India to boost production of combat medicines, pharma dept told to prepare list of drugs
New Delhi: India plans to increase the production of combat medicines, including drugs to treat burns, blood replenishers for treatment of trauma injuries such as gunshot wounds, and orthopedic implants. The Department of Pharmaceuticals has been tasked to come up with a list of such medicines and ensure an increase in their production to mitigate health risk from the ongoing conflict with Pakistan. Also Read | Health emergency plan introduced for J&K, portable hospitals in Poonch, Uri The top drug price regulator—National Pharmaceutical Price Regulator (NPPA)—has been directed by the Centre to ensure that the prices of such pharmaceutical items are brought under control. 'The department of pharmaceuticals along with the National Health Systems Resource Centre (NHSRC) is preparing a list of all such medicines used for the treatment of trauma and burn injury, bullet injury and wound etc, so that the production of such pharmaceutical items can be augmented in the country to deal with any health emergency, if needed," said an official familiar with the matter. Also Read | E-pharmacies, chemists at odds as govt mulls a stop to home delivery of drugs A decision to this effect was taken at a meeting chaired by the union health minister J.P. Nadda on Friday to review the preparedness of the health sector. In a war-like situation, health expenditure significantly goes up due to higher demand for medical care, particularly for combat-related injuries and the mental health impacts of conflict. Medicines and surgical equipment like painkillers, antibiotics, gauges, orthopedic implants, blood replenishers among other products are used for the treatment of trauma injuries, bullet or gunshot wounds, etc. Also Read | India should permit easier access to over-the-counter medicines The official added that the top drug regulator has been tasked to review the companies which are manufacturing such products so that they can be and directed to increase the production of such items. 'Similarly, the NPPA has to ensure the price control of these pharmaceutical items." During the meeting, the government the reviewed the medical preparedness for handling emergency cases, deployment of ambulances; ensuring adequate availability of medical supplies including equipment, medicines, supply of blood vials and consumables; hospital readiness in terms of beds, ICU and HDU; deployment of BHISHM (Bharat Health Initiative for Sahyog, Hita and Maitri) Cubes, advanced mobile trauma care units etc. 'A 24*7 control and command centre is being set up in the health ministry to monitor ongoing efforts and support states in the present times and fulfil the requirements of the state/UT governments," the official said. A senior doctor from the burns and plastic department at a government hospital said, 'We are ready to tackle any health crisis and we have adequate number of beds, medical supplies etc. In the event of trauma injury or gun shot injury, medicines like painkillers, antibiotics and requirements of blood get increased." Dr Mahesh Mangal, head of plastic surgery department at Sir Ganga Ram Hospital, said that main war-related injuries are caused by blasts and burns. "A hospital's trauma team comprising plastic surgeons, orthopedic surgeon, neuro surgeon, general surgeon etc, should be capable of saving the life of the patient. Requirement of combat medicine increases during this time—which are life-saving drugs, blood and blood products, fluids, dressings, oxygen, antibiotics and painkillers." Queries sent to the health ministry spokesperson remained unanswered.
The Hindu
10-05-2025
- Health
- The Hindu
Government gives the nod for setting up ‘Jan Aushadi Kendras' at all GGHs in Andhra Pradesh
In a bid to check the retailers' exploitation of consumers and ensure availability of generic medicines at affordable prices, Minister for Health, Medical Education and Family Welfare Y. Satya Kumar Yadav has approved the setting up of Jan Aushadi Kendras at all the 17 Government General Hospitals (GGHs) in the State. These Jan Aushadi Kendras will be run by the Indian Red Cross Society (IRCS) headed by the District Collectors. According to an official release, Mr. Satya Kumar Yadav approved the proposal during a review meeting on Saturday, and also directed the officials to explore the possibility of opening such kendras at the district and area hospitals as well. Fleecing of patients The decision was taken after it came to the officials' notice that the existing operators of generic medical shops at the GGHs were charging a profit margin of anywhere between 50% and 600%. While these stores were at first allocated to the self-help groups and other societies, it was found that private individuals were running them to extract profits. At present, 23 generic medicine stores were functioning at the 16 GGHs, except at the Nandyal GGH. The release said the manufacturers print higher than the original MRP, against which the retailers were offering different discounts at different places on different medicines, and in the process were making huge profits, whose margin was anywhere between 50% and 600%. The officials also noted that the retailers were not storing all the required drugs, and that they make available only 30-40% of these, forcing the patient to shift to branded drugs, which happen to be pricier. The absence of a compulsory billing system was also leading to sale of medicines for higher profits. Launched in 2008 as Jan Aushadhi Scheme by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, the now-renamed 'Pradhan Mantri- Bharatiya Jan Aushadi Pariyojana' (PM-BJP) enables supply of quality generic drugs at affordable prices to the patients across the country. Under the scheme, the Department of Pharmaceuticals procures generic drugs with standard MRP, printed for supplying to the Jan Aushadi shops, which in turn sell them with only 15% profit margin. Every sale is to be recorded on the special software developed by the Central government that prevents malpractices. The Jan Aushadi stores sell only generic medicines, and if the same is not available for a particular disease, they sell branded ones, after approval from the authorities.
