FDA publishes GMP guidance for Cosmetic products; USFDA to increase its inspections in India; Drug companies ordered to disclose global regulators’ action

[IGMPI India]

GMP Newsletter Friday, July 5, 2013 FDA publishes GMP guidance for Cosmetic products US FDA published a document stating new Good Manufacturing Practice Guidelines for Cosmetic Products. The guidelines aim at assisting the identification of standards and issues related to the quality of cosmetic products. The guidelines reinforce the Federal Food, Drug and Cosmetic Act for prohibition of introduction of adulterated cosmetics. CLICK HERE to read more For details of our Post Graduate Diploma in Good Manufacturing Practices (E-learning) VIEW NOW ------------------------------------------------------------------------------------------ USFDA to increase its inspections in India In view of the recent controversies regarding GMP violations by many pharmaceutical firms, the USFDA plans to increase their foreign audits as there has been a rise in drug plants outside the US and are registered by the FDA. CLICK HERE to read more UK Drug regulator reviews Ranbaxy’s regulatory issues In relation to the recent Ranbaxy Labs regulatory issues, taking an indication from the US Department of Justice, the UK drug regulator, Medicines and Healthcare products Regulatory Agency (MHRA) CLICK HERE to read more Caution letter against Ranbaxy drugs withdrawn by IMA Indian Medical Association - Tamil Nadu State branch withdraws the caution letter it had sent to its members in prescribing the drugs manufactured by Ranbaxy Laboratories. As reported by the authorities, after the media news on the Ranbaxy -FDA issue, CLICK HERE to read more Drug companies ordered to disclose global regulators’ action As per the new order issued by the Drug Controller of India (DCGI) pharmaceutical companies will now have to disclose to the Indian government if there are any alerts sent or restrictions laid on their facilities in India by the overseas drug regulators. This mandate of rigorous disclosures on safety alerts of overseas drug regulators came after CLICK HERE to read more USFDA gives a green signal for new HIV and migraine tablets Indian Pharmaceutical firm, Aurobindo Pharma announced to have received tentative approval from the USFDA to manufacture and market tablets used for treating a type of HIV infection. The approval is to manufacture and market these combination tablets - efavirenz, CLICK HERE to read more Australian regulator says Ranbaxy drugs are safe Just after the UK drug regulator (MHRA) clarification on the Ranbaxy issue, the Australian drug regulator, Australian Therapeutic Goods Administration (TGA), also said that the drugs marketed by Ranbaxy Labs are safe. As stated by the TGA authorities CLICK HERE to read more Indian Government marks harmful drug combos After the action against the popular anti diabetic drug, the government is acting to regulate harmful and irrational combination medicines existing in the market. This will make the drug manufacturers to prove their safety and efficacy claims. CLICK HERE to read more India increases drug inspection staff Central Drugs Standard Control Organization (CDSCO), which is the national regulatory body in India for pharmaceuticals and medical devices, is considered as an Indian counterpart of the USFDA. CDSCO announces to increase CLICK HERE to read more ___________________________________________________________________ To reach our advisors or for any inquiry send an email to in...@igmpiindia.org. For the details of our GMP training programs VIEW For reading our GMP Articles VIEW