Overview of the CDSCO License Mandate The Central Drugs Standard Control Organisation (CDSCO) is the regulatory body that manages medical device registration in India under the Ministry of Health & Family Welfare. The main aim of CDSCO is to ensure that medical devices are...
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It has been decided by the Expert Committee constituted by the Ministry of Health & Family Welfare that there should be provision for providing ancillary care to patients suffering from any other...
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CliniExperts Services can assist the wholesale traders or manufacturers interested in importing small quantity of cosmetics into India for R&D and testing purpose. Complete guidance on documentation and other formalities are provided to...
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Rule 97 of Drug & Cosmetics Act 1945, provides for printing caution/ Warning in respect of drugs covered under Schedule H, Schedule G and substance covered under the purview of Narcotic &...
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The Union health ministry has constituted two expert committees to formulate policy guidelines and standard operating procedures (SOPs) for approval of new drugs, clinical trials, banning of drugs and Fixed Dose Combinations...
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In the Drugs and Cosmetics Rules, 1945 (i) After rule 122DAA, the following rule shall be inserted, namely;- “122-DAB – Compensation in case of injury or death during clinical trial- 1) In...
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As per the new regulations under rule 122 DD, CDSCO has made it mandatory for all Ethics committee to get registered with CDSCO so as to get authority to review and accord...
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“DCGI has made it mandatory for all manufacturers and importers who have obtain new drug permission to submit Periodic Safety Update Reports of new drug every six months for the first two year and...
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No cosmetic shall be imported into India unless the product is registered under the rules by the licensing authority appointed by the Central Government under rule 21 or by any Person to...
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