May 11, 2021 11:18 PM IST
The Hyderabad-based company has entered into a royalty-free, non-exclusive voluntary licensing agreement with Eli Lilly for the manufacture and marketing of the drug in India.
- May 05, 2021 09:45 AM IST
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
- May 03, 2021 11:19 AM IST
CDSCO is responsible for approval of drugs, conduct of clinical trials, laying down the standards for drugs, control over the quality of imported drugs in the country and coordination of the activities of state drug control organisations.
- Apr 16, 2021 02:16 PM IST
The Centre has now announced it will fast-track approval to foreign drug companies whose Covid-19 vaccines have already been approved by the drug certification agencies of the United States, United Kingdom, Japan, European Union and the World Health Organization. But that does not mean the number of steps to vet the vaccine or the requirements for it to be commercially sold has been reduced. We detail the exact process that will determine how long it will take for foreign vaccines to be jabbed in the arms of Indians.
- Jan 25, 2021 08:56 PM IST
India's CDSCO says Pfizer officials failed to turn up to meetings after the company's application was made in early December. The regulator has also declined to accept the company's request for approval without a small local trial on the vaccine's safety and immunogenicity for Indians
- Jul 07, 2020 07:15 PM IST
The filter is intended to be used in the critically ill COVID-19 patients in need of blood purification where excessive inflammatory mediators are present, Baxter India said in a statement.
- May 07, 2020 08:18 PM IST
The import licence has been issued by the drug regulator due to the emergency health situation in public interest, Roche Diagnostics India said in a statement.
- Nov 19, 2019 08:42 PM IST
The CDSCO under the Ministry of Health regulates the safety, efficacy and quality of notified medical devices under the provisions of Drugs and Cosmetics Act, 1940 and Rules made thereunder.
- Nov 04, 2019 03:42 PM IST
Niti Aayog’s Medical Devices (Safety, Effectiveness and Innovation) Bill is the latest in India's seemingly never-ending attempt to introduce a comprehensive and effective medical device regulation, which seems to be reaching a jubilee year of sorts.
- Jul 26, 2019 05:01 PM IST
Recently, global pharma giant Johnson and Johnson was directed to pay compensation to the patients who received faulty hip implants made by the firm.
- Jul 04, 2019 03:42 PM IST
The potential risks are related to the wireless communication between Medtronic's Minimed insulin pumps and other devices such as blood glucose meters, the remote controller and CareLink USB device.CDSCO urges healthcare providers and patients to remain vigilant and not share their pump serial number
- May 22, 2017 12:36 PM IST
"Bepotastine is a new second generation antihistamine medicine to be introduced into the Indian Pharmaceutical Market (IPM) which could benefit millions of patients suffering from allergic symptoms.
- Mar 17, 2017 09:15 PM IST
Unlike the US and Europe, India does not currently have a tracking system for the drug supply chain.
- Jun 02, 2016 03:17 PM IST
Priya Sheth of CNBC-TV18 reports that the regulator plans to categorically outline aspect of post-marketing safety of drugs. These new regulations may cut approval timeline by more than half for biosimilars.
- May 09, 2016 03:18 PM IST
Joint inspections with eight other regulators carried at six of Ranbaxy‘s laboratories in Himachal Pradesh found discrepancies in testing, stability standards and expiry dates, among other standards.
- Jul 31, 2015 04:45 PM IST
The government proposes to introduce regulatory norms and standards for alcoholic beverages, the Lok Sabha was informed on Friday.
- May 04, 2015 07:40 PM IST
CDSCO is looking into the matter a few days after a complaint was filed against Snapdeal for selling prescription drugs online by FDA.
- Mar 14, 2014 03:38 PM IST
Agreeing to examine the allegations against supplying adulterated drugs, a bench headed by Chief Justice P Sathasivam, however, refused to pass any interim order for restraining the company from manufacturing drugs.
- Feb 22, 2014 01:17 PM IST
India supplies about 40 percent of the generic and over-the-counter drugs consumed in the United States, making it the second-largest supplier after Canada. Yet quality control problems have long plagued India's drug industry, largely due to a weak regulatory system.
- Nov 14, 2013 10:06 PM IST
Testing of new drugs for efficacy has slowed to a trickle in India and that has dashed hopes that the clinical trial industry would grow into a billion dollar industry by 2016.
- Oct 21, 2013 01:23 PM IST
The company has received approval from the Central Drug Standard Control Organisation (CDSCO) to manufacture and market SynriamTM in India for the treatment of uncomplicated malaria in adults caused by Plasmodium vivax parasite, Ranbaxy Laboratories Ltd said in a statement.
- Jul 08, 2013 09:06 AM IST
With hardly any drug maker coming forth to prove safety and efficacy of 'new drugs' introduced in India without proper approval, the country's apex drug regulator has asked all such manufacturers to apply before it by August 30 or face prohibition of the drug.
- May 11, 2012 04:52 AM IST
Global drugmakers could face new US scrutiny after a report from lawmakers in India alleged abuses in that country's drug approval process, lawyers familiar with such investigations said.
- May 10, 2012 03:46 PM IST
Swiss drugmaker Novartis said on Thursday it would investigate alleged drug approval irregularities in India after a Parliamentary report found the country's regulator colluded with pharmaceutical firms to speed up approval procedures.