India’s CDSCO gives nod to sell 19 new drugs in 2024

India’s apex drug regulating authority, the Central Drugs Standard Control Organisation (CDSCO), has approved 19 new drugs so far in the year 2024. These includes many next-generation patented novel therapies and first-in-class drugs for chronic diseases like cancers, developed by global pharma majors. India's leading drug companies like Sun Pharma, Dr Reddy's, Lupin, Cipla and Zydus Life Sciences have been able to rope in partnerships or marketing alliances to bring these medications to India. Many global majors are also launching their drugs directly in India. In 2023, the CDSCO permitted about 27 new drugs for marketing and manufacturing in India.

One prime approval in early January was Eli Lillys's Mounjaro (tirzepatide) injection. Reportedly, Eli Lilly will launch this diabetes and obesity treatment drug in India in 2025. The blockbuster drug, launched in the US a couple of years ago, is forecasted to reach global sales of $27 billion by 2029, overtaking Novo Nordisk‘s Ozempic (semaglutide) in the same weight loss market.

A notable new drug development in India during the year was permission for Chennai-based Orchid Pharma to manufacture and market its new chemical entity (NCE), the active pharmaceutical ingredient (API) Enmetazobactam. Orchid Pharma’s new combination drug, Cefepime and Enmetazobactam, as a dry powder injectable, addresses the urgent need for effective treatments against severe infections caused by resistant bacteria. Orchid has teamed up with domestic major Cipla Ltd to sell the drug in various markets.

In February, Cipla Ltd also got the CDSCO approval to market a novel antibiotic - plazomicin, a key development in solving anti-microbial resistance. It is a new Intravenous (IV) drug indicated for the treatment of complicated urinary tract infections (cUTI). UTIs are a global health problem, affecting approximately 150 million patients each year, and the emergence of drug-resistant uropathogens has posed a big challenge in the management of UTIs. Cipla USA Inc., a subsidiary of Cipla, holds the patent for plazomicin sulfate, administered once daily. The company possesses global rights for this molecule, excluding Greater China, and is the innovator of the ZEMDRI brand. Cipla USA Inc. currently markets the product in the USA, where it received approval from the US FDA in 2018.

Similarly, India’s leading drug maker Sun Pharmaceutical Industries got approval in India for Etifoxine Hydrochloride capsules, used in treating anxiety-related disorders excessive worry, tension, and restlessness. Sun now sells the drug in India as Tranxiety. In October, Dr Reddy’s Laboratories launched Elobixibat in India, a first-in-class drug to cure acute constipation with its brand name BixiBat. Around 12% of India's population have chronic constipation, and 40% of people on treatment are unsatisfied with existing medications, according to studies related to the launch of the drug. The drug was developed by Albireo AB and was licensed to Ferring Pharmaceuticals for further development. Albireo partnered with Ajinomoto Pharmaceuticals of Japan to further develop the drug and market it throughout Asia.

In August, Sun Pharma introduces a novel treatment, STARIZO (Tedizolid Phosphate), in India for acute bacterial skin and skin structure infections. Sun Pharma obtained rights from MSD to develop, manufacture and commercialise Tedizolid Phosphate in India. Hetero Drugs is currently undertaking a Phase III clinical trial of a drug of the same family.

Another noticeable launch in India was Zydus Lifesciences and Lupin launching ‘Vault’ (Vonoprazan) in India under non-exclusive patent licensing agreements with Takeda of Japan. Vonoprazan is a next-generation drug used in the treatment of stomach ulcers and gastroesophageal reflux disease (acid reflux). Similarly, the Serum Institute of India developed 'Siltibcy', a skin test diagnostic aid for the detection of Mycobacterium tuberculosis-derived antigens (rdESAT-6 and rCFP-10).

Many new next-generation cancer drugs are also coming to India. The CDSCO Subject Expert Committee permitted Eli Lilly this year to import and market Retevmo (selpercatinib) 40 mg and 80 mg, an anti-cancer drug largely used in treating non-small cell lung cancer and thyroid cancers. Zydus Life Science was permitted during the year to market and manufacture an anti-cancer drug nelarabine injection 250 mg/50 mL. This medicine is primarily used to treat patients suffering from T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma who haven't responded well to other chemotherapy treatments. Dominated by GlaxoSmithKline and Novartis in the global market, the global Nelarabine market was valued at $137.9 million in 2023 and is forecast to reach $148.4 million by 2030.

Sun Pharma's gynaecological drug Elagolix tablets, Bristol Myers Squibb (BMS)'s cardiology drug Mavacamten, lung cancer drug Brigatinib marketed under the brand name Alunbrig by Ariad Pharmaceuticals etc. are some of the new drugs approved in recent months and will be launched in India.