Drug Information Bulletin (Electronic)

Volume: 4

Drug Information Centre (DIC) Indian Pharmaceutical Association, Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291

Number: 26

9th October 2010

Content IP can be claimed for standard strength of dosage forms, not for altered strength: IPC Govt suspends import/manufacture of rosiglitazone with immediate effect Boehringer Drops Female Desire Drug Pfizer Recalls Bottles of Stinky Lipitor Govt. Notification on suspension of import / manufacture of rosiglitazone Felicitation of Dr. G. K. Murthy & Sri P. D. Sheth at Ranchi Forthcoming Events The move is expected to indirectly control the dose metrics to improve quality of medicines marketed in India, according to a senior official from IPC. The clarification of IPC that it intends usual strength of medicines when IP standards are concerned is expected to gradually make the companies stick on to the usual strengths rather than introducing new strengths of medicines which requires clinical investigation to prove the safety and efficacy prior to marketing. For instance, the IP given for paracetamol tablets are for the usual strengths of 300 mg and 500 mg. The tablets having other strengths cannot be claimed to be paracetamol IP. "The quality parameters for such drugs should be as those applicable to paracetamol tablets IP in the matter of identity, purity etc and for strength it will be of licensing authority's stipulation," announced the commission. The strength prescribed in IP is deemed to

IP can be claimed for standard strength of dosage forms, not for altered strength: IPC In an effort to strictly adhere to the drug regulations and to improve the quality of medicines by having a control on the dose metrics, the Indian Pharmacopoeia Commission (IPC) has clarified to the industry that only the drugs of strengths prescribed in the previous edition of Indian Pharmacopoeia (IP) or recommended by the drug regulatory bodies could claim IP - 2010 standard for dosages. The additions made in the latest volume of IP are based on usual strength as available in the previous edition of IP or other current pharmacopoeias, usual strength available from the inputs given by the regulatory bodies including the recent updates in dose metrics from the Drug Controller General of India (DCGI) and with the inputs given by industries, clarifies the commission.

2 be the recognized strength and the quality parameters of IP apply to them. IP does not preclude licensing of other strength subject to such regulatory norms as may be available or applicable to new drugs. In such cases the quality parameter for the particular drug should be those applicable to that category of drug in general, as applicable to the usual strength and such other norms that may be prescribed by licensing authority. The factors considered for addition of monograph in IP are basically the safety and efficacy of the drugs that have been established and prevailing in the country in respect of such strengths. Strength that are not usually recognized are supposed to be new or proprietary drugs as defined in the rules, said a higher official from IPC. Govt suspends import/manufacture of rosiglitazone with immediate effect Following its ban in Europe and the restricted use in the US, the union health ministry has suspended the import or manufacture of the controversial diabetes drug rosiglitazone in the country with immediate effect. A decision to this effect was taken by an Expert Committee constituted by the ministry to examine safety issue and to recommend regulatory action to be taken in country in respect of continued marketing of rosiglitazone in the country in view of its ban in Europe and restricted use in US. A meeting of the Expert Committee was held on October 7, 2010 and it recommended the suspension of import/manufacture of rosiglitazone and its fixed dose combinations in the country with immediate effect as its continued use would lead to more cardiovascular events and adverse effects on lipid profile, Drugs Controller General of India (DCGI) Dr Surinder Singh said. The DCGI has directed all the state drugs controllers in the country to suspend all the licences granted to manufacture for sale and distribution of rosiglitazone and its fixed dose combinations with other drugs with immediate effect. Rosiglitazone and its formulations as single drug or as combinations are being marketed in the country as anti-diabetic drugs. European Medicines Agency in its press release dated 23 September, 2010, has recommended the suspension of the marketing authorisations for the rosiglitazonecontaining anti-diabetes medicines, and the US Food and Drug Administration (US FDA) had also announced on the same day that it will significantly restrict the use of the diabetes drug rosiglitazone to patients with type 2 diabetes who cannot control their diabetes on other medications. Boehringer Drops Female Desire Drug Germany's Boehringer Ingelheim said it will discontinue development of its investigational compound flibanserin for the treatment of Hypoactive Sexual Desire Disorder because of FDA requests for further support the efficacy and safety profile of the drug. The decision was not made lightly, considering the advanced stage of development, said a Boehringer executive. Pfizer Recalls Bottles of Stinky Lipitor Almost 200,000 bottles of the anti-cholesterol drug Lipitor were recalled in August because of a smell, Pfizer said yesterday. In a statement to CNN, Rick Chambers, a Pfizer spokesman, said the "uncharacteristic odor" involved bottles from another company. He said a total of seven batches of Lipitor totaling 191,000 bottles were recalled in the U.S. and Canada. The FDA posted a recall notice yesterday.

Govt. Notification on suspension of import / manufacture of rosiglitazone

Dr. C. Gopalkrishna Murthy-President, IPA, is being felicitated by the Vice Chancellor of BIT - Prof. Ajay Chakrabarty at Ranchi on behalf of IPA, Jharkhand Branch

Sri P.D. Sheth Vice President, FIP, is being felicitated by the Vice Chancellor of BIT - Prof. Ajay Chakrabarty at Ranchi on behalf of IPA, Jharkhand Branch

Forthcoming Events:

A Partners Forum on Womens and Childrens Health

12-14 November 2010, Vigyan Bhawan, New Delhi Convened by The Partnership for Maternal, Newborn & Child Health Hosted by The Government of India

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