Health ministry to amend Form 12-B of D&C Rules

  • Posted on: 11 April 2015
  • By: editor2

 

Health ministry to amend Form 12-B of D&C Rules; Form 12-B of the Drugs and Cosmetics Rules is  for giving permission for import of small quantities of drugs for personal use. The Union health ministry will soon amend Rules in this regard.

The newly formed Drugs Technical Advisory Bpoard (DTAB) has also given its final nod to  amend the D&C Rules in this regard. Form 12-B of the Drugs and Cosmetics Rules  indicates any drug imported for personal use but not forming a part of bona fide personal package is allowed to be imported by the licensing authority in Form 12-B as permit for import of small quantities of drugs for personal use. Clause (3) of the Form 12-B provides the validity of the permit for six months from the date issue as: "(3). This permit shall, unless previously suspended or revoked, be in force for a period of six months from the date specified.

As the patients suffering from certain long term diseases like Wilson diseases should administer drugs on long term basis for treatment or prevention. They are therefore require to clear their permit every six months for continuation. By considering this problem, the health ministry proposed to the DTAB that the above clause may be amended to increase the validity to permit by the licensing authority wherever considered necessary . The DTAB after deliberations agreed to the proposal of the Health Ministry to amend Form 12-B of the D&C Rules for permit for import of small quantities of drugs for personal use.


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