Pharma News

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.

A Divisional Court of the Delhi High Court upheld a single judgment ordering Cipla to be restricted from selling its respiratory illness - Indaflo. Cipla launched the drug on the Indian market in 2014 under the name Unibrez, while demanding the revocation of five Novartis patents on Indacaterol, the generic version of respiratory medicine.

The Delhi High Court allowed the Indian companies Alembic and Natco Pharmaceuticals to export - for research and regulatory purposes - generic versions of two life-saving drugs developed by Bayer Germany.

Medical devices such as stents, heart valves and orthopedic implants will soon have to declare the maximum retail price (MRP) and consumers will no longer have to remain obscure about their exact costs.

Patients suffering from drug-resistant tuberculosis may soon have access to Delamanid, one of two new drugs to get approval for the treatment of tuberculosis after more than 40 years. The drug was added to the kitty shrinking choices to treat multi-drug resistant (MDR) and resistant to resistant tuberculosis (XDR) shortly after bedaquiline.