The National Pharmaceutical Pricing Authority (NPPA) has newly fixed or revised prices of 119 formulation packs and issued corrigendum orders on two insulin formulation packs for which it has revised prices in March, 2009.
Even as the district collectors in several states have started executing recovery proceedings against several pharma companies for overcharging of various drug formulations, the National Pharmaceutical Pricing Authority (NPPA) has clarified that individual companies are welcome to approach the NPPA for redressing any grievances regarding the overcharging issue.
Drugmakers, such as Dr Reddy’s Laboratories, Wyeth, GlaxoSmithKline (GSK) Pharmaceuticals and Alkem Laboratories, may now have to face state officials for failing to pay up penalties for overpricing.
The excise duty reduction from 8 per cent to 4 per cent, announced by the central government on December 8, 2008 as part of a stimulus package to the industry to tide over the sagging economic scenario, is likely to continue after the end of this financial year as the economic downturn, analysts believe, is yet to be bottomed out.
Ethex Corporation, a subsidiary of KV Pharmaceutical Company, is issuing a voluntary nationwide recall of prescription prenatal and iron supplements products (all lots within their expiration dates) at a wholesale level.
Pfizer and Wyeth announced that they have entered into a definitive merger agreement under which Pfizer will acquire Wyeth in a cash-and-stock transaction currently valued at $50.19 per share, or a total of approximately $68 billion. The boards of directors of both companies have approved the combination.
The Union Ministry of Health and Family Welfare has issued guidelines on pre-clinical and clinical studies for the Ayurveda, Siddha and Unani (ASU) medicines through a notification of draft rules adding new rule in the Drugs and Cosmetics Act, 1945.
New Delhi: Ministry of Law and Justice has notified the long awaited Drugs and Cosmetics (Amendment) Act, 2008 (26 of 2008) on 5th Dec, 2008 in Gazette of India (extraordinary) Part-II, section 1.
Consequent upon the reduction in the rate of Excise duty on medicines from 8% to 4% notified by the Ministry of Finance, Department of Revenue, all manufacturers and marketing companies of formulations packs are advised to ensure that the benefit of this excise duty reduction and the reduced rate of abatement is passed on to the consumers through reduced Maximum Retail Price (MRP). The National Pharmaceutical Pricing Authority (NPPA) in India has asked the pharmaceutical companies to reduce the MRP.
The National Pharmaceutical Pricing Authority (NPPA) has revised the prices of vitamin C bulk drugs, hiking them upto 50 percent. The pricing authority revised prices of seven bulk drugs including vitamin C, ibuprofen and analgin.
Thallion Pharmaceuticals Inc. announced that the first patient has been enrolled in its Phase II trial evaluating TLN-232 as a treatment for metastatic melanoma in patients who have failed one prior therapy.
Gilead Sciences Inc has been notified that Teva Pharmaceutical Industries Ltd is seeking U.S. regulatory approval to sell a generic version of Gilead's HIV drug Truvada.
Drug price regulator National Pharmaceutical Pricing Authority (NPPA) has revised the prices of 149 medicines, including monocomponent insulins, dettol antiseptic and aspirin with combinations. The brands concerned are from companies such as Eli Lilly, Shreya Life Sciences, Reckitt Benckiser, Aventis Pharma, Wockhardt and Pfizer Products.
Ipsen announced that the US Food and Drug Administration (FDA) provided notification that the Prescription Drug User Fee Act (PDUFA) action date for Dysport (botulinum toxin of type A) Biologics License Application (BLA) for the treatment of patients with cervical dystonia has been extended to no later than 28 December 2008. This regulatory decision will not impact the anticipated company launch plan timing.
Ipsen announced that the U.S. Food and Drug Administration (FDA) provided notification that the Prescription Drug User Fee Act (PDUFA) action date for Dysport® (botulinum toxin of type A) Biologics License Application (BLA) for the treatment of patients with cervical dystonia has been extended to no later than 28 December 2008.
Galapagos NV announced that it has received a transparency notification from Delta Lloyd, disclosing that they hold a 5.4% interest in the share capital of Galapagos.
The Union Ministry of Finance has announced the anti-dumping duty imposed on the third generation parenteral cephalosporin antibiotic ceftriaxone sodium sterile imported from China as per the final recommendations of the Directorate-General of Anti-Dumping and Allied Duties (DGAD).
Barr Pharmaceuticals has announced that its subsidiary, Barr Laboratories has received final approval from the FDA to manufacture and market a generic version of Ortho McNeil Janssen's Razadyne, 4mg, 8mg and 12mg tablets. Barr intends to launch its generic Razadyne tablets product immediately.
As part of the annual exercise, the National Pharmaceutical Pricing Authority (NPPA) has revised the norms for conversion costs, packaging charges, process loss of materials and packaging material costs, by effecting upto 9 per cent differences.
Panacea Biotec, one of India's leading research-based health management companies, has received an award notification for supply of its pentavalent vaccine – EasyFive, for years 2008 and 2009 from UNICEF. The total value of the award is US$ 34.2 million (around Rs 143 crore).