Page 2 - Drug Makers In India

60 drug makers join govt scheme to modernise pharma manufacturing units

Indian pharmaceutical companies recently came under the scanner after global supplies of certain medicines were found to be toxic

USFDA highlights quality concerns over drugs manufactured in India

USFDA launches QMM program to reduce drug shortages and improve supply chain issues

CDSCO cracks whip on drug manufacturing units over quality lapses

Shuts down 36% of facilities for failing to meet quality standards

Regulatory action: Shock and awe

Rather than surprising investors with their final decisions, disclosing findings on an ongoing basis would better prepare the market for eventual outcomes

Govt planning regulatory crackdown on look-alike, sound-alike drug names

In order to safeguard patients, the Drug Technical Advisory Board (DTAB) proposed banning the production and marketing of distinct drugs under identical brand names

Domestic drugs formulations market to be worth Rs 5.5 trn by 2034: Report

'Significant under-penetration' in domestic market, especially in smaller towns and rural areas

NPPA fixes retail prices for 54 drug formulations and 8 special products

Prices have been fixed for drugs and formulations meant for diabetes, hypertension, heart issues, multivitamins, bacterial infections, and allergies

Indian pharmaceutical companies likely to cash in on US drug shortages

US drug shortages hit a decade-high of 323 across 22 therapies in the March quarter of 2024

Drug makers Dr Reddy's, Sun Pharma, Aurobindo recall products in US market

Drug makers Dr Reddy's Laboratories, Sun Pharma and Aurobindo Pharma are recalling products in the US market due to manufacturing issues, as per the latest Enforcement Report of the US Food and Drug Administration (USFDA). Dr Reddy's Laboratories is recalling close to 20,000 cartons of a medication used to control blood phenylalanine levels in adults and children. Princeton (New Jersey) based Dr Reddy's Laboratories, Inc, is recalling Javygtor (sapropterin dihydrochloride) Powder for Oral Solution (100mg) due to it being a "Sub-potent Drug", USFDA stated. The company is also recalling another lot of sapropterin dihydrochloride for the same reason, it added. The USFDA said the drug maker initiated the Class I recall in the US on April 8 this year. As per the US health regulator, a Class I recall pertains to defective products that can cause serious health problems. The USFDA said Sun Pharma is recalling 11,016 vials of Amphotericin B Liposome for Injection, used to treat fungal ...

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'