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It is acknowledged within the pharmaceutical industry that clinical trials represent the single most expensive aspect of a drug, or treatment, development process. Specifically, clinical trials are enormously resource-intensive and involve repetitive,...

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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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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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File no. X11026/306/11-BD Dated 18 Jan 2013 In order to update the Quality information of already licensed products in a systemic approach it has been decided to submit the updated PPD of...

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The "Guidelines on Similar Biologics" prepared by Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) lay down the regulatory pathway for a similar biologic claiming to be similar...

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G.S.R. 588(E) – whereas certain draft rules further to amend the Drugs & cosmetics Rules, 1945, were published, as required by sections 12 and 33 of the drugs & cosmetics act, 1940...

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