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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

  The National Expert Group on Vaccine Administration for the Covid 19, on April 15, 2021, offered authorization for emergency use of the Covid 19 vaccine, which has already been approved for restricted use by the US FDA, MHRA, or those listed for emergency use in WHO. But certain conditions are satisfying which the applicant will get permission for making use of vaccines for restricted use like The vaccine must follow all guidelines as per the National Covid 19 vaccination program. For the first seven days after administration, the first 100 persons will be closely monitored. Within 30 days of vaccine approval, the applicant should start post-approval bridging clinical trials. Steps for processing the application. All manufacturers of vaccines outside India can apply for getting approval through the Indian Subsidiary or any authorized agent in India according to the rules under the Drugs and Cosmetics Act, 1940. The applicants can apply through the SUGAM online portal with a

The Union health ministry plans to modify the New Drugs and Clinical Trials (NDCT) rules 2019 for E compassionate utilization of novel unapproved drugs depending on the Drugs Technical Advisory Board (DTAB) recommendations. DTAB measured the draft notification about the same dated June 5, 2020, after proper consideration is recommended to alter the rules, including some of the provisions for compassionate utilization of novel drugs that have not obtained approval. After a discussion with DTAB, the central government had released draft guidelines on June 5, 2020, about making some alterations in NDCT rules, 2019, for compassionate utilization of novel but unapproved drugs. It has also asked for suggestions on the draft guidelines from the industry. DTAB explained that the depiction of the Cure SMA foundation of India had been received to make the rules and guidelines for the compassionate use of novel but unapproved drugs in India. The whole illustration clearly mentioned that the

Government has extended the validity of the import license along with the registration certificate by six months. This step has been taken to make sure the medicines are available in the country. On July 27 2020, the Ministry of Health and Family Welfare gave a notification affirming that drug supply should not be affected and it should remain accessible to the public. So, due to the ongoing pandemic, COVID-19 pharmaceutical companies have wished for extending the validity of the registration certificates for about six months. Thus, exercising the powers deliberated by section 26B under Drugs and Cosmetics Act, 1940, the central government directed a notice, without withstanding anything in the rule 28A of the Drugs and Cosmetics Rules, 1945 for drugs import for the sole purpose of sale or distribution. That if an existing registration certificate holder as per given rules applies for a fresh registration certificate before expiry of the present, the present certificate will remain v

On September 8 2020, DCGI instructed all manufacturers to follow a definite procedure for regularization of FDCs or fixed-dose combinations. It has directed all to follow a specific pathway for submitting applications of the rational FDCs. CDSCO or the Central Drugs Standard Control Organization has allotted six months to all existing as well as new manufacturers for submission of application for getting the manufacturing as well as marketing approval for FDCs that has been declared rational by DTAB committee The letter depicts that if a manufacturer gives the copy of the product license that has been issued by an SLA to any of the firm specifying that the product in a specified dosage form, as well as strength, has obtained a license before November 28 2007, the same is considered for issuing permission by CDSCO office as per defined pathways. The whole procedure is the same for all FDC including the 3 that have been added recently in the rational FDC list. The pharma market of In

  CDSCO or Central Drugs Standard Control Organization in its recent notification has issued a clarification about the import of diagnostic kits or reagents for research use only for the purpose of academic research. Hence, clarifying the stand on the import of drugs in India . It was clarified that all products that are meant for "Research use only" must be used in academic research institutions and should not be used for any kind of diagnostic or therapeutic purposes and they are not under the regulation of Drugs and Cosmetics Act or Medical Devices Rule. But it is required for the applicant to submit an undertaking at the concerned port office of CDSCO stating that all imported products must be used by research institutions for the sole purpose of academic research. It should not be used for any kind of in-vitro diagnostic or therapeutic purpose in any diagnostic labs or hospitals. The notification was issued dated 19th June 2020. All such products must be clearly