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  • Dr Reddy's signs licensing pact with Eli Lilly to produce COVID-19 treatment drug Baricitinib May 11, 2021 11:18 PM IST

    Dr Reddy's signs licensing pact with Eli Lilly to produce COVID-19 treatment drug Baricitinib

    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.

  • New guidelines by drug regulator CDSCO clears way for import of foreign COVID-19 vaccines like Sputnik V May 05, 2021 09:45 AM IST

    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

  • Natco gets CDSCO nod for emergency use of Baricitinib tablets for COVID-19 treatment May 03, 2021 11:19 AM IST

    Natco gets CDSCO nod for emergency use of Baricitinib tablets for COVID-19 treatment

    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.

  • EXPLAINED | What is the exact mechanism for foreign vaccines to get approval in India? Apr 16, 2021 02:16 PM IST

    EXPLAINED | What is the exact mechanism for foreign vaccines to get approval in India?

    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.

  • COVID-19 vaccine update | Pfizer wants India to order coronavirus vaccine before pursuing approval Jan 25, 2021 08:56 PM IST

    COVID-19 vaccine update | Pfizer wants India to order coronavirus vaccine before pursuing approval

    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

  • Baxter India gets CDSCO nod for use of its Oxiris filter in COVID-19 treatment Jul 07, 2020 07:15 PM IST

    Baxter India gets CDSCO nod for use of its Oxiris filter in COVID-19 treatment

    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.

  • Roche Diagnostics India gets import licence for COVID-19 antibody test kit from CDSCO May 07, 2020 08:18 PM IST

    Roche Diagnostics India gets import licence for COVID-19 antibody test kit from CDSCO

    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.

  • Niti Aayog has not rejected proposal to bring medical devices under CDSCO: Govt Nov 19, 2019 08:42 PM IST

    Niti Aayog has not rejected proposal to bring medical devices under CDSCO: Govt

    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.

  • Health | India must close the tortuous discussions on medical device regulation Nov 04, 2019 03:42 PM IST

    Health | India must close the tortuous discussions on medical device regulation

    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.

  • Govt constitutes committee for regulation of medical devices Jul 26, 2019 05:01 PM IST

    Govt constitutes committee for regulation of medical devices

    Recently, global pharma giant Johnson and Johnson was directed to pay compensation to the patients who received faulty hip implants made by the firm.

  • Drug regulator warns of hacking risk in Medtronic insulin pumps Jul 04, 2019 03:42 PM IST

    Drug regulator warns of hacking risk in Medtronic insulin pumps

    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

  • Lupin gets CDSCO approval for anti-allergy drug May 22, 2017 12:36 PM IST

    Lupin gets CDSCO approval for anti-allergy drug

    "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.

  • New e-platform to help India weed out substandard drugs Mar 17, 2017 09:15 PM IST

    New e-platform to help India weed out substandard drugs

    Unlike the US and Europe, India does not currently have a tracking system for the drug supply chain.

  • New guidelines to cut approval time of biosimilars in half Jun 02, 2016 03:17 PM IST

    New guidelines to cut approval time of biosimilars in half

    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.

  • More trouble for Ranbaxy as central regulator finds deficiencies May 09, 2016 03:18 PM IST

    More trouble for Ranbaxy as central regulator finds deficiencies

    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.

  • Govt proposes to introduce standards for alcohol Jul 31, 2015 04:45 PM IST

    Govt proposes to introduce standards for alcohol

    The government proposes to introduce regulatory norms and standards for alcoholic beverages, the Lok Sabha was informed on Friday.

  • Online sale of drugs under regulator CDSCO's scanner May 04, 2015 07:40 PM IST

    Online sale of drugs under regulator CDSCO's scanner

    CDSCO is looking into the matter a few days after a complaint was filed against Snapdeal for selling prescription drugs online by FDA.

  • SC notice to Centre, Ranbaxy on PIL for licence cancelation Mar 14, 2014 03:38 PM IST

    SC notice to Centre, Ranbaxy on PIL for licence cancelation

    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.

  • US not targeting Indian drug companies in crackdown: FDA Feb 22, 2014 01:17 PM IST

    US not targeting Indian drug companies in crackdown: FDA

    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.

  • Drug trials stuck in red tapes with no takers Nov 14, 2013 10:06 PM IST

    Drug trials stuck in red tapes with no takers

    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.

  • Ranbaxy gets CDSCO nod to sell malaria drug 'SynriamTM' Oct 21, 2013 01:23 PM IST

    Ranbaxy gets CDSCO nod to sell malaria drug 'SynriamTM'

    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.

  • DCGI asks drug manufacturers to get clearance before Aug 30 Jul 08, 2013 09:06 AM IST

    DCGI asks drug manufacturers to get clearance before Aug 30

    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.

  • India drugs inquiry could prompt new US scrutiny May 11, 2012 04:52 AM IST

    India drugs inquiry could prompt new US scrutiny

    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.

  • Novartis to probe Indian drug approval allegations May 10, 2012 03:46 PM IST

    Novartis to probe Indian drug approval allegations

    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.

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