Pharma firms will have to affix barcodes on consignments of all tertiary level packaging, such as cartons, following a government order.
Orchid Chemicals & Pharmaceuticals (Orchid) on Wednesday announced that it has entered into an exclusive agreement with STADA Pharmaceuticals, the US subsidiary of STADA Arzneimittel, for the development and supply of six prescription generic drug pr
Mumbai-based Sun Pharmaceuticals has filed a post-grant opposition with the Mumbai patent office against a product patent granted to the extended release version of Johnson and Johnson's (J&J) blockbuster drug Risperdal, used in the treatment of psychological disorders and schizophrenia.
Maya Chemtech India Pvt Ltd supplied propylene glycol used in Marion Biotech's cough syrups that were found to be "not of standard quality", according to the regulator.
Western drugmakers, including Pfizer Inc, Novartis AG, Roche Holding AG and Sanofi SA, covet a bigger share of the fast-growing Indian drugs market.
It was in 2005, India changed its patent law and started granting patents in medicines.
Sharad Pawar says final draft will go to Cabinet before Tuesday.
The idea is to ensure drug companies do not gold-plate drugs to exorbitantly raise prices while introducing those in the market.
NPPA will begin analysing pricing trends of 74 bulk drugs that come under the government-notified price-controlled list every quarter.
After the first quarter was washed out, exporters are now keeping their fingers crossed over a turnaround in outbound shipments to at least North America from September onwards. This comes even as other key destinations such as Europe may take longer to revive in FY24. Slowdown in key economies, as well as geopolitical tensions resulted in sluggish demand for Indian goods.
The BSE Healthcare Index is up 19 per cent as compared to BSE Sensex returns of 11 per cent during this period. Nitin Agarwal of DAM Capital highlighted this trend in a report last month. "After a sustained period of underperformance over FY21-23, the BSE Healthcare Index has once again captured the spotlight. "The recent uptick in performance has been driven by hospitals and emerging green shoots in pharmaceutical exports, particularly to the US, along with sustaining momentum in domestic branded formulations," he said.
Ranbaxy Laboratories on Monday said it has received tentative approval from the United States Food and Drug Administration to manufacture and market anti-hypertension drug Quinapril Hydrochloride in the US.
Pharmaceutical companies in Himachal Pradesh are queuing up to register new products at the drugs controller's office before the seven-year tax holiday window for hill states ends on March 31
Food and Drug Authority Ghana said in a statement that officials of Bliss GVS Pharma of India and Ghanaian drug maker Tobinco Pharmaceuticals have apologised to it for importing 'fake malaria medicine' to Ghana to treat malaria in children.
The government's decision to impose excise duty on the maximum retail price of all drugs -- which took effect from January 8 -- may have an adverse impact on the domestic operations of drug makers, said analysts.
The idea is to keep a close watch on real-time price movements, the maximum retail price of medicines and their availability.
The list of guests included celebrities from across the globe, politicians, the who's who of Hindi and south Indian cinema world and almost all the top cricketers of the country.
The company has received final approval for its supplemental New Drug Application (sNDA) for Antara (Fenofibrate) capsules in 30 mg and 90 mg strengths from the United States Food and Drug Administration (USFDA), Lupin Ltd said in a statement.
The South African government and large pharmaceutical companies are in combat mode regarding the proposed national policy on intellectual property that hopes to improve access to medicines for the poorer sections of the population.
AstraZeneca on Wednesday announced that it had filed separate patent infringement actions in the United States District Court, Delaware, against seven generic drug manufacturers, which have submitted abbreviated new drug applications (ANDAs) with the US Food and Drug Administration (FDA) seeking marketing authorisation for Crestor.
Wockhardt is recalling select drugs in the US, which were under import restrictions from the USFDA.
Dr Reddy's on Monday said it would acquire Switzerland-based Roche's bulk drug business in Mexico for $59 million.
Hit by the new drug pricing policy and regulatory interventions, growth rate of the Rs 72,069-crore Indian pharmaceutical market has slowed down to 9.8 per cent in 2013 as compared to 16.6 per cent in 2012, says a report.
Indian drug firms continue to work closely with the FDA, and most have also appointed consultants to help them grasp the regulatory minutiae in the US.
The PhRMA's observation is significant against the backdrop of Swiss pharma major Novartis AG's decision to relocate its R&D investments from India.
Hyderabad-based pharma company Hetero Drugs Ltd said on Monday that it had been chosen by the Clinton Research Foundation as one of the four Indian pharmaceutical companies.
The government should take measures to promote innovation and R&D while simplifying regulations for the sector in the upcoming Union Budget, as per pharmaceutical industry bodies. Outlining the wish list for the sector in the upcoming Union Budget, Indian Pharmaceutical Alliance (IPA) secretary general Sudarshan Jain said the domestic pharma industry is currently around $50 billion in size and aspires to grow to around $130 billion by 2030 and $450 billion by 2047. "To achieve this vision, the Union Budget 2023-2024 should help fuel innovation and R&D, which will set the pace for propelling the pharmaceutical industry forward," he told PTI.
Govt bans brands with annual sales worth Rs 3,728 crore.
But, the process patent that existed previously had already allowed for a huge number of cheaper generics. Even so, within two months, Pfizer's Viagra had exceeded its own expectations by capturing 1.8 per cent of the market, worth around Rs 80 crore (Rs 800 million). It set an example and gave hope to other pharma companies to launch their products in India.
They seek to profit from big-selling drugs going off-patent this year in the lucrative market.
In comparison, Indian companies received only 23 out of 139 final approvals (16.54 per cent) in the corresponding period in 2006.
The anti-depressant drug market in the US is primarily ruled by Effexor XR (Venlafaxine) of Wyeth (now owned by Pfizer).
Indian drug makers may lose out on outsourcing contracts as overseas pharmaceutical companies defer their visits to the country in the wake of Mumbai terror attacks, according to industry experts.
