Page 4 - Drug Makers In India

Medical device companies get a three-month extension for licences

The step comes after several medical device associations and stakeholders had sent representations to the drug regulator, asking for an extension to adhere to the new licensing regulations

NPPA revises ceiling prices of 923 scheduled drug formulations from April 1

The formulations in the new revised rate list include essential drugs such as painkillers, antivirals, antibiotics, antimalarials, and drugs for type 2 diabetes

Centre seeks more time to frame policy on online sale of medicines

The Centre has urged the Delhi High Court to grant some time to frame a policy on the online sale of medicines on the grounds that the issue was "complex" and any modification in the manner of sale of drugs would have far-reaching consequences. The high court granted the Union Ministry of Health and Family Welfare four months as a last and final opportunity to frame the policy. A bench of Acting Chief Justice Manmohan and Justice Manmeet PS Arora made clear that "if the draft policy is not prepared before the next date of hearing, this court will have no other option but to proceed ahead with the matter". The high court, which was hearing several petitions seeking a ban on the "illegal" sale of drugs online and challenging the draft rules published by the ministry to further amend the Drugs and Cosmetics Rules, listed the matter for further hearing on July 8. It had earlier asked the Centre to file a status report on the petitions. During the recent hearing, the joint secretary of

Govt revamps pharma scheme, entails financial assistance to drug cos

The Department of Pharmaceuticals has revamped a scheme which entails financial assistance to drug companies to help them upgrade their facilities to produce medicines conforming to global standards, an official release said on Monday. As per the revamped Pharmaceuticals Technology Upgradation Assistance Scheme (PTUAS), the government has expanded the scope of the initiative beyond MSMEs to include any pharmaceutical manufacturing unit with a turnover of less than Rs 500 crore that requires technology and quality upgradation, the Chemicals and Fertilisers ministry said in a statement. Preference however remains for MSMEs, supporting smaller players in achieving high-quality manufacturing standards, it added. The revamped scheme also introduces more flexible financing options, emphasising subsidies on reimbursement basis, over traditional credit-linked approach. This flexibility is designed to diversify the financing options of the participating units, facilitating a more widesprea

Strides Pharma receives USFDA approval for neurology medication Gabapentin

Gabapentin is widely used in managing neuropathic pain associated with diabetic neuropathy, postherpetic neuralgia, and central pain

'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