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The Central Drugs Standard control organization, or CDSCO, has modified its guidance for the industry for post-approval changes in biological products quality safety and efficacy documents. It has eliminated the provisions of the automatic approval of all post-approval changes, thereby making it mandatory for all companies to file for fresh new drug or manufacturing licenses for all products with the regulator. As per the recent guidance issued by the drug regulator under the Drugs and Cosmetics Act, all the applicants for biological products who make any change in their development after approval must apply for new drug permission if in case there are any changes as per rule 2 (w) of New Drugs and Clinical Trial Rules, 2019. For any change in the manufacturing, premises must get approval for an already approved product, the respective licensee should apply for the extra product permission to the individual state licensing authorities along with the zonal office and the sub-zonal offic

Gam- COVID Vac combines vector vaccine SPUTNIK V of Dr.Reddys Laboratories is being offered for preventing coronavirus disease 2019 caused by SARS-Cov-2. The fact sheet is given here assists you in understanding all the risks and the benefits of the vaccine. This vaccination is carried out in two stages. The first stage is with component 1, then after three weeks with component 11. The product is given intramuscularly. The first dose of 0.5ml is given, and then after three weeks, an amount of 0.5ml is given. After administering the vaccine, the patient must be monitored by a competent healthcare professional for about 30 minutes. There are certain things you need to know before you get this vaccine shot. The vaccine has got permission for getting used in an emergency situation. It has not obtained the marketing authorization, but its approval for restricted use grants permission for getting used for active immunizations of those individuals who are above 18 years for preventing C

The Union Health and Family Welfare Ministry has issued a notification on the execution of Drugs and Cosmetics Rules 2020 that states that marketers and manufacturers are responsible for giving assurance about the quality and regulatory compliances of the marketed drugs in the country with regulatory process for import and export of drugs in India . On February 13, 2020, the Ministry of Union Health and Family Welfare made a declaration for replacing a clause that contains the definition of "Marketer" which implies a person who is an agent or in any other capacity that adopts any drug that is manufactured by any other manufacturer under an agreement for drug marketing by labelling his name on the drug label given its sale and distribution. In addition to this amendment, Rule 83C, Rule 84D and Rule 84E have been inserted in the Drugs and Cosmetics Rules, 1945 for defining agreement for marketing and responsibility of marketer of the drugs. The rule 84E comprises responsibi

CDSCO or the Central Drugs Standard Control Organization has recently made it clear about the need for the process validation report to obtain the permission to conduct Clinical trial/ BA-BE studies. Under this notification, it has ordered all state drug controllers to submit the bioavailability- bioequivalence study agreements for export in 15 days along with approvals for production as well as imports of novel drugs and its complete analysis in seven days. Clinical trials and BA-BE studies are an important part of the regulatory process of import and export of drugs in India . The permission needed to do BA/BE analysis of all novel drugs for the sole purpose of export is given by the Central Licensing Authority (CLA), according to the New Drugs and Clinical Trial Rules, 2019, in the form CT-07. Import license in the form Ct-17 is also given for import of the analyzed drug. The approvals manufacture new and/or unapproved API and finished formulations for doing clinical trials (C