Pharma News

The Health Ministry says that Acitretin will be included in Schedule H after making an amendment in the Drugs Rules, 1945. Acitretin is an oral retinoid used in the treatment of severe resistant psoriasis.

Schedule H is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules, 1945. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor. The manufacture and sales of all drugs are covered under the Drugs and Cosmetics Act and Rules.

GlaxoSmithKline plc announced that ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi & Co. Limited Shionogi as shareholders, has agreed to settle the global patent infringement litigation between GSK, Shionogi and Gilead Sciences, Inc. Gilead concerning ViiV Healthcares patents relating to dolutegravir, an antiretroviral medication used, together with other medicines, to treat human immunodeficiency virus.

Pfizer Inc and BioNTech SE announced that following a request from the U.S. Food and Drug Administration the companies have initiated a rolling submission seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age 6 months to <5 years of age, in response to the urgent public health need in this population. The companies expect to complete the EUA submission in the coming days.

Alembic Pharmaceuticals Limited announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fesoterodine Fumarate Extended- Release Tablets, 4 mg and 8 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Toviaz Extended-Release Tablets, 4 mg and 8 mg, of Pfizer Inc. (Pfizer).

The clinical and imaging characteristics of COVID-19 breakthrough infections in fully vaccinated patients tend to be milder than those of partially vaccinated or unvaccinated patients, according to a new multicenter study published in the journal Radiology.

The number of confirmed COVID-19 cases worldwide now exceeds 270 million with an overall mortality rate of approximately 2%.

Pharmacy Council of India proposed to the principal secretary, Health or technical education of all states and union territories that M.Pharm pharmacy practice to be included as qualification for clinical pharmacist besides Pharm.D.

The Pharmacy Council of India (PCI) is a statutory body working under the Ministry of Health and Family Welfare. Government of India, New Delhi. It is constituted under the Pharmacy Act, 1948 to regulate the profession and practice of pharmacy in the country.

Pfizer Inc and Ionis Pharmaceuticals, Inc announced the discontinuation of the Pfizer-led clinical development program for vupanorsen (PF-07285557), an investigational antisense therapy that was being evaluated for potential indications in cardiovascular (CV) risk reduction and severe hypertriglyceridemia (SHTG).

Zydus announced that the company has started the supplies of its COVID-19 vaccine ZyCoV-D, to the Government of India against their order from its newly commissioned state-of-the-art, Zydus Vaccine Technology Excellence Centre at the Zydus Biotech Park in Changodar, Ahmedabad. The group is also planning to make the vaccine available in the private market. ZyCoV-D is a three dose vaccine administered intradermally using the painless PharmaJet® needle free system, Tropis®, on day 0, day 28 and day 56.

Budget 2022 disallows pharmaceutical companies to claim tax cut on freebies to doctors under section 37 of the act. It simply means such expenditure can not be claimed as business deduction, and it will be counted as taxable profit of pharmaceutical industries.