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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

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

  Till now in India only notified medical devices are under the regulation of Drugs and Cosmetics Act 1940 and Rules in 1945 as Drugs. But CDSCO or Central Drugs Standards Control Organization has streamlined the application procedure for issuing free sale certificate, market standard certificate as well as a non-conviction certificate of the notified medical devices in India. This movement has been undertaken for guiding the Indian manufacturers or the importers of the medical devices for submission of application for obtaining those certificates. As per the notification, it is applicable only for those medical device manufacturers or the importers present in India having a valid manufacturing license or the drugs import license and wish to obtain a Market Standing Certificate or Non-Conviction Certificate of the notified medical devices in India. This notification was released on 30th September 2020. As per the notification, an online application will be sent to CDSCO for notifi

  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

  Hand sanitizer has become an important part of our lives and this is now available everywhere. Starting right from the big pharmacies to small shops, they are now available for the general public. These sanitizers fall under the purview of drug product registration in India . Before Covid-19 it was mostly considered a novel product and was used by very few people. But after the pandemic, the market became flooded with a ton of hand sanitizers that claim to kill germs. Such was the impact that the government had to finally intervene and put a cap on prices. As per the latest guideline, an efficient alcohol-based hand sanitizer must have alcohol between 70-80 per cent. A hand sanitizer that contains 70% isopropyl alcohol is the best one to disinfect the hands. As per FDA guidelines the hand sanitizers should have a specified level of 80% ethyl alcohol or 75% of isopropyl alcohol and according to WHO, hand sanitizers should contain 80% alcohol and 75% isopropyl alcohol. As per DCG

The Ministry of Health and Family Welfare on March 16, the year 2020 has banned the import of two important drugs in India beneath the power given by the Drugs and Cosmetics Act, 1940. These two drugs are Chenodeoxycholic acid and Ursodeoxycholic acid. They are no more eligible for pharmaceutical product registration in India . The reason behind the ban is that both drugs Chenodeoxycholic acid and Ursodeoxycholic acid which is extracted and then prepared from porcine sources are more likely to possess a certain risk to the health of living beings that includes both human beings and animals. Thus it was necessary for Government to expedient to prevent the drug import as per public interest. These two banned drugs are extracted from the biles of domestic pigs as well as the Asian black bears. China also possesses farms for bile extraction but these farms have got severe criticism from international global animal rights organizations because of the inhumane and unhygienic extraction p

Government of India has framed some new rules for blood centers and the blood components under Drug and Cosmetics rules, 2020 for better compliance as per the Drug Technical Advisory Board (DTAB) recommendations. According to the gazette notification, the government has made the rules to amend the Drugs and Cosmetic rules, 1945 which is to be known as Drugs and Cosmetics rules 2020. As per the Drugs and Cosmetics Rules , 1945, in part XB and part XII B, in the heading in place of blood banks the word blood centers shall be used. In the said rules it has been stated that: “The blood centre is one of the authorized premises present in an organization or an institution whatever may be the case, for operating all or part of the operations that includes collection, processing, strong and distribution of the blood that is drawn from any donor or obtained from a licensed blood centre for the sake of preparation, storing and circulation of the blood components.” In the stated rules 122