Drug Regulator

The DGCI has said that even after the instructions from apex regulator for compliance of the order of Delhi High Court, the e-pharmacies were found to be engaged in selling medicines online without license.

S Eswara Reddy rejoins as joint drug controller after Centre revokes suspension

The Delhi High Court granted both Reddy and Biocon's associate vice president Praveen Kumar bail.

New guidelines by drug regulator CDSCO clears way for import of foreign COVID-19 vaccines like Sputnik V

Dr Reddy's Laboratories, the custodian of the Sputnik V vaccine in India, has already announced the arrival of 1.5 lakh doses as first consignment of the 250 million doses it plans to import from Russia; Pfizer is reportedly negotiating an expedited approval pathway for the use of its vaccine in India

USFDA exempts more products from import alert: Divis Labs

The regulator had earlier exempted 10 products, including Levetiracetam, Gabapentin, Lamotrigine, Capecitabine, Naproxen sodium and BOC core succinate, from the import alert.

Which sectors remained in the limelight in FY17? What next for them?

A look at the performance of sectors during the current fiscal and how they would perform going forward.

US regulator set to begin inspection of Dr Reddy's Srikakulam unit on March 27

Dr. Reddy’s said it spent about $35-40 million on remediation work that includes legal and professional charges.

Here’s what analysts feel about Dr Reddy’s Labs post US FDA observations

Typically, the US drug regulator conveys its concerns on manufacturing practices through Form 483. Companies that receive its observations must respond in writing with a corrective action plan and implement it quickly

Divi’s Labs plunges 17% on US FDA import alert on Vizag unit

The US Food and Drug Administration issued the import alert for the company’s Visakhapatnam unit-II, which contributes 60-65 percent to total sales of the firm.

Glenmark rises 4% on receipt of inspection report from US FDA

The drug firm received establishment inspection report (EIR) from the US Food and Drug Administration on closure of inspection of its Ankleshwar plant in Gujarat.

Alembic Pharma soars 7% on USFDA inspection clearance

The US drug regulator had inspected its Baroda unit between March 6 and 10 and issued no Form 483s for the same.

Glenmark Pharma up 1% on US FDA nod to drug's first phase

The US drug regulator cleared the company‘s investigational new drug application to begin phase two study of GSP 304 that will be used to treat chronic obstructive pulmonary disease.

Cadila Healthcare falls 7% on US FDA observations at Baddi plant

The US Food and Drug Administration (FDA) gave three observations under Form 483 for its formulations manufacturing facility at Baddi. These were related to pre-approval inspections for a specific product filed.

Panacea Biotec up 13% on US FDA nod for migraine drug

US FDA gave a clearance to the company's drug Rizatripan Bonzoate tablet, which is used to treat symptoms due to migraine.

Will submit clarification to EMA on clinical study data:Alkem

Drug maker Alkem Laboratories today said it will submit 'suitable clarifications' to the European Medicines Agency (EMA) over a decision by the drug regulator to review two drugs for which clinical trial studies were conducted by the Mumbai-based firm.

NPPA fixes price of 70 drug formulation packs

"NPPA has fixed ceiling prices of 70 scheduled formulations of Schedule-I under Drugs (Price Control) Amendment Order, 2016, and retail price of two formulations under DPCO, 2013," NPPA said in a statement.

Ranbaxy products sold in India safe, says drug controller

Analysts point out that the US FDA gave Ranbaxy adequate time, almost a year, to rectify these lapses. It would however be important to now understand, what went wrong with Ranbaxy‘s remediation plans and processes so as to attract the strict action of an import ban from the US FDA, a year after the issues were first reported.

Glenmark gets US nod for alcohol dependence treatment drug

Glenmark's Acamprosate Calcium delayed release tablets are a generic version of Forest Labs' Campral. The drug had sales of USD 21 million for 12-months ended March 2013, according to IMS Health data.

Wockhardt plunges after Macquarie downgrades to 'neutral'

While the stock valuations still remain supportive, multiples could be under pressure in the near to medium-term, driven by uncertainty around remediation timelines and future approvals, Macquarie says.

UK drug regulator recalls medicines made by Wockhardt

The MHRA says it has identified manufacturing deficiencies at Wockhardt's plant at Waluj in Maharashtra.

Glenmark, Natco get final US nod for anti-migraine drug

Rizatriptan Benzoate orally disintegrating tablets are a generic version of Merck's Maxalt MLT Tablets.

Sun Pharma gets US FDA nod for Riluzole 50mg tablets

Riluzole is used to treat amyotrophic lateral sclerosis. Sun Pharma had received tentative approval for the drug from US FDA in 2010.

Wockhardt tanks 20% on US FDA import alert

The US drug regulator has issued an import alert on Wockhardt's facility at Aurangabad in Maharashtra. The stock closed down 20 percent, its lower circuit level, at Rs 1,313.80 on NSE.

Innovation vs cheap healthcare: What is the priority?

Global pharmaceutical giant Bayer has challenged the compulsory license granted by India‘s drug regulator to local generic firm Natco and the hearing begins on the August 21.