3rd October 2022 | Pharma Updates

Latest pharmaceutical industry news and updates

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DCGI committee suggests ban on 14 out of 19 cocktail drugs

The Drugs Controller General of India which has the apex advisory board recommended banning 14 drugs in the fixed-dose combination category. The list of banned drugs include codeine-based cough syrups like Dr Reddy’s Dialex DC, Mankind’s TedyKoff, Codistar and so on.

Pharma companies file litigation against recent circular issued by Ministry of Finance

Many independent Pharma companies and also the Karnataka drugs and Pharmaceuticals Association have moved to Karnataka HC mentioning that the samples provided by Pharma companies to doctors don’t come under freebies and thus won’t be eligible for TDS (tax deduction at source).

NIH to fund compassionate use of unapproved ALS drugs under patient-backed law

The National Institute of Health is going to spend $25 Million to finance patients in compassionate use (open access) program for unapproved drugs according to a new law. This will be open to patients diagnosed with deadly diseases with only a few options available.

Punjab police busts Inter-state Pharmaceutical drug racket involving NDPS

A Haryana resident was caught by Punjab Police carrying more than 2.5 Lakh pharma Opioids.The Fatehgarh Sahib district police stated that this is the third such racket that has been caught in less than three months.

Eskayef receives US FDA accreditation for injectables manufacturing unit in Bangladesh

Eskayef Pharmaceuticals Limited is one and only of its kind company in Bangladesh to have received such a prestigious accreditation for its injectables facility. With the issuance of the approval, the company will now be able to export its injectable products to US market.

US FDA issues form 483 with two observations to Zydus Lifesciences

Zydus Lifesciences announced that US regulatory authority conducted a PAI (Pre Approval Inspection) at the SEZ, Ahmedabad facility of Zydus Animal Health and Investments Limited from 23rd-29th September’2022, after which they issued a form 483 two observations.

BioMarin applies again to seek approval for hemophilia gene therapy in US

After receiving a nod from the European Health Authority and positive data from trials up their sleeve, the company resubmitted the application to US FDA for the approval of its drug named Valrox indicated to treat severe Hemophilia A in adults. 

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