Pharmaceutical

In a major crackdown against the manufacture of substandard drugs, central and state regulators conducted joint inspections at 76 pharma companies and cancelled the licences of 18 of them for producing spurious and adulterated drugs, official sources said on Tuesday. The inspections were carried out across 20 states and Union territories in the past 15 days, they said. A source said that the action has been taken against 76 companies in the first phase of a special drive against the manufacture of substandard drugs. "Licences of 18 pharma companies have been cancelled for manufacturing spurious and adulterated drugs and for violating GMP (good manufacturing practice).... Besides, 26 firms have been given show-cause notices," an official source said. The sources said that as part of the special drive, the regulators have identified 203 firms. A majority of the companies are from Himachal Pradesh (70), followed by Uttarakhand (45) and Madhya Pradesh (23). Recently, questions have b

Margins to remain healthy on the back of cost-saving measures

INCB chief Jagjit Pavadia said, "India has witnessed the rise of commercial chemical factories that have been adapted to illicitly manufacture large quantities of synthetic drugs and their precursors"

Bristol Myers Squibb, a world's leading biopharmaceutical company will establish a state of-the-art site here to expand its global drug development and IT capabilities with an investment of Rs 800 crore, a Telangana government press release said on Thursday. The announcement was made after Telangana Minister KT Rama Rao's meeting with Samit Hirawat, Executive Vice-President, Global Drug Development at BMS, who is in the city to participate in BioAsia 2023, it said. The company plans to begin operations in Hyderabad later in 2023, with the potential over the next few years to employ approximately 1,500 people who will be engaged in cutting-edge Research and Development and digital activities, a BMS release said. Rama Rao said, "I am delighted to welcome Bristol Myers Squibb to the vibrant ecosystem of Hyderabad. It is indeed a matter of pride that BMS, which is one of the most innovative and world leading biopharmaceutical companies, has chosen Hyderabad and I strongly believe this .

Govt should not solely depend on monetary incentives

The sectors in India that import from China include pharmaceutical (pharma), automotive (auto), textile, engineering, and electronic goods

High raw material prices to put pressure on margins

To launch open offer for another 26%; plans merger with Cohance

Alembic Pharmaceuticals on Monday said it has received final approval from the US health regulator for its generic Fulvestrant injection used in treatment of breast cancer. The approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA), Fulvestrant injection of strength 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, the company said in a statement. The approved injection is therapeutically equivalent to the reference listed drug product (RLD), Faslodex Injection, of AstraZeneca Pharmaceuticals LP, it added. Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of breast cancer, the company said. For 12 months ended September 2022, Fulvestrant injection, 250 mg/5 mL, had an estimated market size of USD 71 million, the company said citing IQVIA data.

'Irreparable damage' to Indian pharma's global image, drug regulator writes to WHO

Companies will have to manage work to match India's National List of Essential Medicines but it will be worth the endeavour, she says

With the acquisition, Gland pharma may also get access to global companies like AstraZeneca, Sanofi, Mylan, and Organon

Pre-clinical trials of new drugs could soon be done on human tissues and cells developed in laboratories and not just on animals as the Union Health Ministry is working on bringing in amendments to the New Drugs and Clinical Trials Rules, 2019. A recent draft notification to amend the rules stated that alternative technology platforms such as human organ on chips, micro-physiological systems and other in vitro or cell-based assays can be used prior to and in conjunction with animal testing to establish the safety and efficacy of new drugs before human clinical trials. Pre-clinical tests are important for establishing the safety and efficacy of investigational drugs. In September, the US Congress approved a landmark FDA Modernization Bill that allows a pharmaceutical drug developer to use alternative methods -- including cell-based assays, organ on chips, micro-physiological systems and other human biology-based test methods -- for establishing the safety and effectiveness of new or

Key antibiotic brands like Augmentin (GSK) and Clavam (Alkem) clocked 25 per cent and 29 percent growth, respectively, in November, the data showed

Merck's anti-diabetic molecule sitagliptin retains 81% market share in value terms

In a Q&A, the recently named MD & CEO of Biocon Biologics dwells on the scope for an IPO or stake sale to PE investors to retire the debt taken to fund the acquisition

Will fund transaction from internal accruals

Its local production ramp-up remains unhurried as demand for boosters reduces

Rising Chinese labour costs, geopolitics, pandemic-stricken uncertainties have forced global players to derisk

Leading contract manufacturing drug firm Akums Drugs & Pharmaceuticals plans to expand its presence globally and enhance product range as it looks to more than double its turnover to Rs 10,000 crore by 2028, as per the company's Joint Managing Director Sandeep Jain. The company, which produces around 12 per cent of all the medicines consumed in the country from its 15 manufacturing facilities, has a topline of about Rs 4,000 crore currently. In an interaction with PTI, Jain said the company would be able to achieve its stated financial targets even if it continues to grow at the same pace it has been doing over the last few years. He noted that the demand for pharmaceutical products is going to stay robust in the domestic market, with some estimates pointing towards the market doubling by 2030. "We expect to touch a turnover of Rs 10,000 crore in the next five years (2028)from the current level of Rs 4,000 crore. Our plan is to keep growing by at least 12-15 (CAGR)," Jain ...