Government News

Small and medium-sized generic drug manufacturers in India say that the threat of stricter rules and higher barriers for foreigners in the US healthcare market will force a lot to find a niche or focus their expansion efforts on other countries.

The Ministry of Health is considering setting up an online portal to regulate and fill gaps in the sale of drugs in India across all platforms, including pharmacies. "The objective of such regulation would be to ensure the availability of drugs that meet quality standards to each person in need of medicines, to curb antimicrobial resistance and to regulate the supply of drugs online, "The ministry said.

Both Johnson & Johnson and Danish partner Bavarian Nordic have induced a lasting immune response for a full year in 100% of vaccinated healthy volunteers, researchers reported. The world should be much better prepared for the next Ebola epidemic, with other promising results showing the potential of a long-lived lethal virus vaccine.

The policy, which had been pending for more than two years, also suggests raising public health spending to 2.5% of GDP, compared with 1.2% currently. EU Health Minister J P Nadda is expected to make a statement on the policy in Parliament.

The NPPA drug price regulator has capped the prices of four essential drugs and revised 14 others, including those used for the treatment of fungal infections and hypertension.

Since its inception, the National Pharmaceutical Pricing Authority (NPPA) has published 1,527 notices of demand to companies for surcharges on sales of formulations at prices above the notified ceiling price. Drug price regulator NPPA received Rs 672.28 fine crore up to date from pharmaceutical companies for overcharge, Parliament was informed.

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The main brands of some of the drugs used for the treatment of heart disease and diabetes are up to 10 times higher than generic drugs, the government said.

More than 20 medical devices that are notified as "drugs" must all carry the maximum retail price on packages, the NPPA drug price regulator said. These devices include cardiac valves, surgical dressings, condoms, stents, disposable hypodermic syringes and orthopedic implants.

The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) have jointly developed a 'Handbook for Applicants and Reviewers of Clinical Trials of New Drugs in India'. The main objective is to guide applicants and reviewers of clinical trial applications and commercialization (import, manufacture, sale) of new experimental drugs (INDs) and new drugs (NDs) in the country

Taking into account strict national and international guidelines for the conduct of clinical trials, ICMR has decided to undertake clinical trials for regulatory submissions and for academic purposes. India is a signatory to the WHO Global Tuberculosis Strategy, which was endorsed by the World Health Assembly in May 2014.