Submit report on any adverse reaction to pelvic mesh, J&J told

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  1. The Indian government has written to US based pharmaceutical company Johnson & Johnson to furnish details of the number of surgical pelvic meshes it has imported into India in the last three years.
  2. The government’s move comes in the backdrop of the U.S Food and Drug Administration(FDA) banning the transvaginal pelvic mesh after women have blamed the company’s product as responsible for their injuries.
  3. The pelvic mesh is a medical device popularly used to support the abnormal descent of the pelvis in women.It is a cloth-like piece of netting made of synthetic material that is used to provide additional support to weakened or damaged tissue; for instance, after childbirth or due to increasing age.
  4. Recently,Drugs Technical Advisory Board(DTAB) had also recommended amendment to Rule 26 of the Drugs and Cosmetics Rules,1945,which deals with conditions under import licences.
  5. This move comes after the Government had found Johnson & Johnson guilty of supplying faulty hip implants in India and had ordered the company to pay over ₹74 lakh to a Mumbai-based patient as compensation
  6. The proposed amendment makes it mandatory for import license holders to maintain control samples of imported drugs.In case of drugs bearing an expiry date on the label,the reference samples shall be maintained for a period of three months beyond the date of expiry or potency.

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