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| Govt allows restricted manufacture, sale, distribution of human placental extract | | | EARLY TIMES REPORT
JAMMU, JULY 13- The Government of India, on the recommendations of a high level committee appointed by the High Court of Delhi, has amended the item No (4) of the third paragraph of its notification, allowing “Human Placental Extract and its formulations for topical application for wound healing and injection for pelvic inflammatory disease, subject to various conditions.
Earlier, the Government of India vide notification No GSR 82E of February 10, 2011 of Ministry of Health and Family Welfare in exercise of the powers conferred to the government by Section 26A of Drugs and Cosmetics Act, 1940 had prohibited manufacture, sale and distribution of Human Placental Extract and its formulations for human use.
According to Controller, Drug & Food Control Organization, Jammu Mr. Satish Gupta, the said notification with respect to its part relating to the drug “Human Placental extraction and its formulations” was challenged in the High Court of Delhi in the writ petition (Civil) No. 1054/2011 and during the deliberations before the High court, the Government gave an undertaking that the issues related to safety, efficacy etc. in respect of the said drug may be examined by a large committee.
On the basis of the recommendations of the expert Committee constituted by the Government as per the directions of the High Court of Delhi, the Central Government has amended the item No (4) of the third paragraph of the aforesaid notification, that “Human Placental Extract and its formulations for human use except its topical application for wound healing and injection for pelvic inflammatory disease, subject to the condition that the manufacturers of Human Placental Extraction and its formulations for human use shall maintain meticulous details and traceability of the donors of the placenta so as to ensure that the placenta is collected from the donors who are free from HIV, HBsAg, HCB and other viruses”. |
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