Page 3 - Drug Makers In India

DCGI introduces new traceability rules to address fake medicines issue

The new guidelines have been formulated by India's drug regulatory body to ensure product traceability, which has been hindered by insufficient documentation throughout the distribution network

Abbott India Q1 results: PAT rises 13% to Rs 328 cr, income at Rs 1,625 cr

Drug firm Abbott India on Wednesday said its net profit increased by 13 per cent year on year to Rs 328 crore for the first quarter ended June 30, 2024. The company reported a net profit of Rs 290 crore in the April-June quarter of last fiscal. Total income rose to Rs 1,625 crore for the period under review as against Rs 1,535 crore in the June quarter of FY24, Abbott India said in a regulatory filing. Shares of the company on Wednesday ended 1.29 per cent up at Rs 28,159.95 apiece on the BSE.

Akums Drugs and Pharma's IPO gets fully-subscribed on Day 1 of offer

The initial public offer of Akums Drugs and Pharmaceuticals got fully-subscribed on the first day of subscription on Tuesday. The Rs 1,875-crore initial share sale received bids for 2,07,92,684 shares, as against 1,51,62,239 shares on offer, translating to 1.37 times subscription, as per the NSE data. The issue will conclude on August 1. The quota for Retail Individual Investors (RIIs) received 3.35 times subscription, while the Non Institutional Investors part got subscribed 1.96 times. The portion for qualified institutional buyers (QIBs) received 43 per cent subscription. The IPO is a combination of a fresh issue of equity shares worth Rs 680 crore and an offer-for-sale (OFS) of 1.73 crore shares valued at Rs 1,177 crore at the upper-end of the price band by promoters and an existing investor. Those selling shares in the OFS are Sanjeev Jain, Sandeep Jain and Ruby QC Investment Holdings Pte Ltd. The public issue has a price range of Rs 646 to Rs 679 per share Akums Drugs and

Govt plans regulatory crackdown on similar-sounding, look-alike drug brands

Drug manufacturers in India will soon be required to upload their product formulations and brand names on the government's portal

Ahead of IPO, Akums Drugs garners Rs 829 crore from anchor investors

Akum Drugs and Pharmaceuticals Ltd on Monday said it has collected Rs 829 crore from anchor investors a day before its share-sale opening for public subscription. Abu Dhabi Investment Authority, Smallcap World Fund, Inc, HSBC Global Investment Funds, SBI Mutual Fund (MF), Bandhan MF, Motilal Oswal MF, Aditya Birla Sun Life MF, SBI Life Insurance Company, HDFC Life Insurance Company and ICICI Prudential Life Insurance Company are among the anchor investors. According to a circular uploaded on NSE's website, the company has decided to allocate 1.22 crore shares to 50 funds at Rs 679 apiece, aggregating the transaction size to Rs 828.78 crore. The issue, with a price band of Rs 646 to Rs 679 per share, will open for public subscription on July 30 and conclude on August 1. The Rs 1,875-crore IPO is a combination of a fresh issue of equity shares worth Rs 680 crore and an offer for sale (OFS) of 1.73 crore shares valued at Rs 1,177 crore at the upper end of the price band by promoters

Sun Pharma open to exploring acquisitions in global specialty portfolio

Sun Pharma has net cash position of $2.4 bn at end of FY24; 6 new specialty products in R&D pipeline

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