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Indian Drug Makers
Central Drugs Standard Control Organisation (CDSCO) has found 41 drug samples tested in the central drug laboratories in November as 'not of standard quality' (NSQ), official sources said. Besides, 70 drug samples tested by the state drugs testing laboratories have also been identified as NSQ in November, they said. Identification of drug samples as NSQ is done based on failure of the drug sample in one or the other specified quality parameters. "The failure is specific to the drug products of the batch tested by the government laboratory and it does not warrant any concerns on the other drug products available in the market," an official said. Two drug samples were identified as spurious drugs in November. Out of the two samples, one was picked by Bihar Drugs Control Authority and the other by CDSCO, Ghaziabad, the sources said. The drugs were made by unauthorised and unknown manufacturers, using brand names of other companies. Action to identify NSQ and spurious medicines is ta
Drug major Cipla expects to commence supplies to the US market from its China facility in the second half of the current fiscal after getting approval from the American health regulator, according to its MD and global CEO Umag Vohra. Addressing shareholders in the company's Annual Report for 2023-24, he noted that the company is working with the USFDA to resolve issues with its various domestic plants. "Although we saw challenging phases with USFDA audits, I am glad to report that our China facility cleared the USFDA audit and is expected to supply to the US by the second half of FY 2024- 25," Vohra said. Sharing updates about other plants, he noted that the facilities of Patalganga and Kurkumbh in India were also cleared with a VAI (voluntary action indicated). "Our Goa site was issued observations and our Indore plant is currently being remediated. Finding resolution for these regulatory issues continues to be our top priority," Vohra said. The company has worked extensively to
Pharma major Lupin Ltd on Thursday said it has received approval from the US health regulator to market its generic Febuxostat tablets, indicated for the chronic management of hyperuricemia in adult patients with gout. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Febuxostat tablets of strengths 40 mg and 80 mg, a generic equivalent of Uloric tablets, 40 mg and 80 mg, of Takeda Pharmaceuticals USA, Inc, Lupin said in a regulatory filing. The product will be manufactured at the company's Pithampur facility in India, it added. The company said Febuxostat tablets of strengths 40 mg and 80 mg are indicated for the chronic management of hyperuricemia (elevated serum uric acid level) in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol; who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Febuxostat tablets had estimated annual sales of U
Taking suo moto cognizance of the drug menace, the Rajasthan High Court on Saturday issued notices to the central and state governments seeking affidavits detailing existing mechanisms to control the "unregulated" production of tablets and syrups containing psychotropic substances. The court also sought information on any mechanisms in place to regulate the distribution of such tablets and syrups to dealers, distributors, and retail pharmacists. The matter came up during a bail application hearing on Saturday, when Justice Farjand Ali took note of a commercial quantity of medicinal drugs allegedly seized from the petitioner. Justice Ali expressed concern over the heavy sale and consumption of tablets, medicinal drugs, and syrups containing psychotropic substances. The court questioned the unregulated operation of city drugstores and called for the identification of sources involved in illegal distribution. The court also noted that despite arrests and detention of drugstore employ