Page 4 - Drug Makers In India

'Two-thirds of greenfield units under PLI for bulk drugs completed'

Union Minister of Chemical and Fertilisers Mansukh Mandaviya on Saturday inaugurated 40 greenfield facilities to manufacture bulk drugs and medical devices under the PLI scheme

Cipla receives approval from drug regulator CDSCO for UTI drug

Plazomicin is a new intravenous (IV) aminoglycoside that has demonstrated efficacy and safety in clinical trials compared to meropenem (antibacterial agent)

Medical groups raise concerns around India-EFTA after leaked documents

Doctors Without Borders (MSF), Public Eye, and Delhi Network of Positive People expressed concern that the deal, which is nearing completion, includes harmful intellectual property (IP) proposals

Doctors should be careful of mefenamic acid's effects: Meftal makers

In the backdrop of a caution by the Indian Pharmacopoeia Commission (IPC) against mefenamic acid, a major component of painkiller meftal, the medicine's manufacturer on Tuesday said the alert seeks to advise doctors and patients to monitor the possibility of an adverse reaction of the drug. "The alert issued by IPC was to advise doctors and patients to monitor the possibility of an adverse drug reaction of mefenamic acid, which does not in any way impact the safety, efficacy and high quality of the brands that are established and supported by clinical studies," Blue Cross Laboratories, which makes meftal and meftal-spas, said in a statement. The IPC on November 30 had issued an alert on mefenamic acid stating that a preliminary analysis of adverse drug reactions from the Pharmacovigilance Programme of India (PvPI) database revealed drug reactions with eosinophilia and systemic symptoms (DRESS) syndrome. "Healthcare professionals, patients/consumers are advised to closely monitor th

Uttar Pradesh to invest Rs 8,000 crore in 1,400-acre bulk drug park

The UP government has already signed 236 memorandum of understanding (MoU) worth Rs 11,000 crore with different companies and consortiums to set up their manufacturing plants

India launches a single-window portal for medical devices management

The Drugs Controller General of India said that the National Single Window System (NSWS) has been established as a 'genuine single-window system which acts as a one-stop shop for all approvals'

Another drug from hospitals found to be of sub-standard quality: Delhi LG

Days after Delhi Lt Governor V K Saxena referred a matter pertaining to drugs failing quality standard tests to CBI, Raj Niwas officials on Wednesday reported another medicine used for treating seizures and epilepsy turning out to be spurious. Saxena had last week recommended a CBI inquiry into the alleged supply of drugs that "failed quality standard tests" and have the "potential of endangering lives." According to officials, another drug sample taken from Delhi government hospitals was failed by the RDTL, or Regional Drug Testing Laboratory, in Chandigarh. This time an anti-epilepsy drug called 'Sodium Valproate' was found to be falling short of the standards. The report was issued by a government analyst on December 22, an official said. The drugs that have been found to be of "sub-standard quality" included Cephalexin, a critical life-saving antibiotic used for the treatment of lung and urinary tract infections, according to officials. They also included Dexamethasone, a ste

Trade generics growth to dent value expansion of domestic drug market

Jan Aushadhi and trade generics together constitute 20-22% of pharma market volumes

Biocon arm, Sandoz to distribute rheumatoid arthritis drug in Japan

BBL launched Hulio, a biosimilar version of Abbvie's blockbuster drug Humira, in the US in July

Govt probe into bribery claim in toxic syrup tests nears completion: Report

Indian-made cough syrups have been linked to the deaths of at least 141 children in Gambia, Uzbekistan and Cameroon since last year

Over 2.9k drugs found to be substandard in tests conducted in 2022-23: Govt

Out of the 89,729 drug samples tested between April 2022 and March 2023, 2,921 drugs were found to be "not of standard quality" while 422 were identified as spurious, the Rajya Sabha was told on Tuesday. In a written reply, Minister of State for Health Bharati Pravin Pawar said 642 prosecutions were launched for manufacturing, sale and distribution of spurious/adulterated drugs, while 262 persons were arrested during the same period as per information received from drugs controllers of various states and Union territories. This excludes data from Rajasthan. Giving details of the previous year, Pawar said a total 88,844 samples were tested between April 2021 and March 2022 of which 2,545 were declared to be not of standard quality while 379 were found to be spurious. She said 592 prosecutions were launched for manufacturing, sale and distribution of spurious/adulterated drugs and 450 persons arrested during the same period. Responding to a question, Pawar said that in order to asse

Zydus Lifesciences receives USFDA approval for Ivabradine tablets

On Friday, shares of Zydus Lifesciences were up/down by 0.34 per cent, ending the day's trade at Rs 640 apiece on the BSE

Sun Pharma and Zydus Lifesciences partner to market kidney drug Desidustat

Under this licensing agreement, Zydus has granted Sun Pharma semi-exclusive rights to co-market Desidustat in India

Sanofi loses $21 bn in market value after dropping 2025 profit target

Sanofi shares trade at a 12 month forward price-to-earnings ratio of 11, a discount to AstraZeneca's 16 and global pharma index of 17, according to LSEG data

Maharashtra has become big market for sale, consumption of drugs: Saamana

Saamana claimed that the drugs that are not being seized by the authorities at the ports of Gujarat are being released into Maharashtra

Drug regulatory reforms for improving quality

A strong drug regulation system is essential for India, as it not only supplies quality drugs to its own population but is responsible for meeting 20 per cent of the global demand

PLI scheme effect? Bulk drug imports from China slow, shows data

Experts say scheme to boost local manufacturing will take 5-7 years to show tangible results

Drug regulator CDSCO finds syrups made by Norris Medicines toxic: Report

The drug regulator for Gujarat state, where Norris is based, told Reuters that its factory had been closed

WHO's good manufacturing norms to be made compulsory for all drug firms

Only 2,000 of the 10,500 manufacturing units in the country have the World Health Organization's GMP certification

DCGI asks states to keep vigil on sale of falsified versions of 2 drugs

The Drugs Controller General of India (DCGI) has directed the drugs controllers of all states and Union territories to keep a strict vigil on the sale and distribution of falsified versions of two drugs, liver medication Defitelio and Takeda's cancer drug Adcetris (injection), following alerts issued by the World Health Organisation (WHO). In an advisory on September 5, the DCGI said the WHO has issued a safety alert identified with multiple falsified versions of Adcetris injection 50 mg manufactured by Takeda Pharmaceutical Company Limited, identified in four different countries including India. "These products are most often available at the patient level and distributed in the unregulated supply chains (mainly online). The products have been identified in both regulated and illicit supply chains, sometimes at patient levels as well. WHO has reported that there are at least eight different batch numbers of falsified versions in circulation," the DCGI said in a communication to the