manual on management of drugs

ANNEXURE XI
Recall procedure for quality failed pharmaceuticals as approved by the
Technical Advisory Committee
Quality failures are identified under 2 categories.
(i) Failures due to manufacturing defects
(ii) Failures related to improper storage
The following recommendations are made about failures due to
manufacturing defects
1. De-registration
a) De-registration of a product
A single product which has been recommended for withdrawal by the
D/NDQAL, it shall be referred to a committee comprising of DGHS
(Chairman), D/MT&S, D/NDQAL, DDG(LS), Consultant/DRA and
DDG/SLSI for the final decision on de-registration.
b) De-registration of a manufacturer
If more than one product of a particular manufacturer that has been
recommended for withdrawal by NDQAL, it will be referred to the
above mentioned committee for the final decision.
2. The manufacturer can re-apply for registration after making necessary
improvements only after a period of 24 months from the date of deregistration
of the product or the manufacturer.
3. Any changes in ownership or name of a manufacturer should be
communicated to the DRA within one month of such a change; in the
event of such changes, the original decision with respect to the drug
or the manufacturer will stand.
4. Re-registration will not be granted until the manufacturing plant is
inspected and approved by the DRA. All costs for inspections will be
borne by the company concerned.
5. The final decision of the recall procedure committee shall be
conveyed to the DESC and Presidents of the Professional
Associations/Colleges whose duty shall be to convey the information
to the registered members of the Colleges or Associations.
86