Central Drugs Standard Control Organization (CDSCO), Government of India has a mandate for approval of drugs to be manufactured and imported for sale in India. The drugs approved by CDSCO can only be further licensed by State Licensing Authorities to various manufacturers in India. CDSCO often publishes the list of approved drugs/ new drugs on […]
Indian drug regulatory system is governed by the provisions laid down under Drugs and Cosmetics Act, 1940 and Rules, 1945 made thereunder. With changing times many new rules viz. Medical Device Rules, 2017, New Drugs and Clinical Trial Rules, 2019 and Cosmetics Rules, 2020 have been introduced. As per the legal requirements any firm […]
Business Continuity is an issue that affects all organizations whether small or large, domestic or multinational. The extent of impact however may vary from organization to organization. Recently, we have witnessed a global pandemic which has disrupt almost all type of businesses. Natural disasters, environmental accidents, technology mishaps, and man-made crises have demonstrated that severe […]
Central Drugs Standard Control Organization (CDSCO) under the aegis of Ministry of Health and Family Welfare, Government of India has been taking many steps to control the menace of unapproved and irrational Fixed Dose Combinations (FDCs). In this process, government has banned many FDCs due to lack of safety and efficacy data. The complete list […]
Aug, 23 2021 USFDA approved the first fully licensed COVID19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), […]
April 21, 2021 Indian Pharmacopoeia Commission (IPC), Ministry of Health and Family Welfare, Government of India has introduced a new draft General Chapter on ‘Approach to Alternative Rapid Microbiological Method’. The proposed methods would enable faster laboratory testing of the drug(s) like Remdesivir injection, thereby making them accessible to the patients at the earliest without […]
India is a country which has a drug regulatory system operating at the Central Level as well as the State Level. At Central level, Central Drugs Standards Control Organization (CDSCO) is the organization which has been given the prime responsibility of approval of New Drugs, Clinical Trials in the country, laying down the standards for […]
Pharmacopoeia is the word derived from the ancient Greek φαρμακοποιΐα (pharmakopoiia), from φαρμακο- (pharmako-) ″drug″, followed by the verb-stem ποι- (poi-) ″make″ and finally the abstract noun ending -ια (-ia). These three elements together can be rendered as ″drug-mak-ing″ or ″to make a drug″. A pharmacopoeia, pharmacopeia, or pharmacopoea, in its modern sense, is a […]
Since the arrival of Coronavirus disease, there has been a flood of advices, do’s and dont’s reaching everyone of us. Social media is full of home remedies, talismans and what not to treat and prevent coronavirus disease. By this article we have tried to provide you facts countering the popular myths circulating around more rapidly […]
Since the advent of Coronavirus disease, the whole world has gone crazy after two things i.e Hand Sanitizers and Face Masks. The fear of the disease has gripped everyone so much that people who didn’t have any exposure to the carrier, are wearing face masks even at home. They are using hand sanitizers like anything. […]
In our previous edition to this article entitled “Hand Sanitizer and COVID – 19 – Understanding the Misunderstood”, we had informed you how washing hands with plain soap and water is considered as more effective than hand sanitizers to prevent Corona Virus Infection. Many more queries were raised by our readers in this context. Hence, […]
Coronavirus disease has taken world by storm. Currently, not even a single country is immune to this deadly disease. What has made the matters worse is the mental stress developed due to fear and anxiety of looming uncertainty. This may become more severe and take a toll on the overall health of the individuals who […]
Apr 2, 2020 EMA has recommended that fosfomycin medicines given by infusion (drip) into a vein should only be used to treat serious infections when other antibiotic treatments are not suitable. Fosfomycin medicines given by mouth can continue to be used to treat uncomplicated bladder infections in women and adolescent girls. They can also […]
Coronavirus disease has taken world by storm. Currently, not even a single country is immune to this deadly disease. Till now, this deadly disease has taken lives of more than 35000 people and more than 750 thousand people are infected worldwide. The virus that causes COVID-19 spreads very easily and sustainably in the community. The […]
API First is a team of regulatory experts who are well versed with the nuances of the regulatory filing and subsequent approval processes of drugs in India as well as other regulatory countries. The team of experts have a vast experience with the drug approval process in India.