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  DCGI has asked the state drug controllers to direct the drug makers to obtain the manufacturing license of 471 novel fixed-dose combinations that are related to the vitamins, minerals along with the micronutrients that have been declared by Prof. Kokate committee as rational and have got approval from DCGI. This has brought great cheers to all the manufacturers of the drugs especially those who are involved in the manufacturing of vitamins, minerals as well as micronutrients. This is in continuance to the DCGI letter to all state DCs in December 2018 and January 2020 where all of the state licensing authorities were directed to ask the respective manufacturers to follow the process for getting the manufacturing licenses from SLA. After approval from the health ministry, it has been decided to follow a specific procedure for granting of product license by SLA in respect of FDC. Applicants have to deposit the required fees through Bharatkosh for every FDC to CDSCO as stated under t

  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

  Health ministry has released a draft classification for non- notified medical devices for its efficient regulation. The Drugs Controller General of India responsible for Drug product registration in India , had notified every stakeholder as well as associations for required comments as well as suggestions for classification of those non-notified medical devices by October 3, 2020, for efficient regulation as per New Medical Device Rules. As per the notice, all suggestions have been effectively sought about the previous gazette notification that was published on February 11, 2020, which stipulates that all medical devices must be regulated in a phase-wise manner. IVDs are classified into class A (low risk), class B (moderate risk), Class C (moderate-high risk) and Class D (high risk). For facilitating the whole procedure for classifying IVD medical devices, all devices are classified into 3 main categories like IVD analyzer, IVD instrument and IVD software and are scrutinized based

  A novel drug makes a great contribution to the welfare of human beings, as it helps in treating a disease or by enhancing the lifestyle of a patient. It also helps in prolonging the life of a person who is suffering from diseases that are not curable. But with every novel drug is associated the risk of side effects. This risk is one of the important concerns in association with proper regulation in the pharmaceutical sector. Such risk can cause detrimental effects for which was accepted as one of the important points to undertake for better regulation. A novel drug means novel molecular entities but in reality, it takes varied forms starting from reformulated generics to some fixed-dose combinations of the existing drugs. It has been provisioned now that all kinds of study that involves humans that are not drug trials will be under the regulation of national ethical guidelines for biomedical and health research. It is now compulsory that ethics committees should be registered with

India's Ministry of Health and Family Welfare has granted permission to manufacturers to produce and stock vaccines for Covid-19 that are under clinical trials for getting marketing authorization for sale or distribution. Thus easing the drug license registration process . This regulation will accelerate the availability of the Covid-19 vaccine in the country sooner after they get approval post trials. This is one of the welcomed and awaited movements by the Ministry during this tough pandemic time. It allows all manufacturers of vaccines to initiate the process of manufacturing synchronously with ongoing clinical trials. If the vaccine trial becomes successful, this movement by the Ministry of Health and Family will help in saving time and the public will get easy and quick access as the vaccine is available immediately after required regulatory permissions. The early launch of Covid-19 vaccine will help in rapid vaccination of Indian public. As per the notifications issued by

  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

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