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DCGI asks cos to submit stability data of non-patent & proprietary drugs with application for mfg license
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Ramesh Shankar, Mumbai
August 29 , 2017
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To ensure quality of drugs, the Drugs Controller General of India (DCGI)
has directed the manufacturers to submit the stability data of
non-patent and proprietary medicines also at the time of submission of
application for grant of permission to manufacture such medicines.
Stating
that stability of drug is of paramount importance to ensure quality,
safety and efficacy of the drugs throughout its shelf life, the DCGI in
his letter to all the state/UT drugs controllers directed the drug
controllers to advise the manufacturers under their jurisdiction to
submit the stability data of non-patent and proprietary medicines also
at the time of submission of application for grant of permission to
manufacture such medicine to ensure quality of products.
The
Drugs & Cosmetics Act, 1940, is an Act, to regulate import,
manufacture, distribution and sale of drugs and cosmetics. The Drugs
& Cosmetics Rules, 1945, made under the Act prescribe statuary
requirements for grant of license to manufacture for sale and
distribution of drugs to ensure safety, efficacy and quality of drugs
manufactured and sold in the country. One of the conditions for grant of
license to manufacture for sale and distribution of patent or
proprietary medicines is that the applicant shall furnish to the
licensing authority evidence and data justifying that the medicines are
stable under the condition of storage recommended, the DCGI stated in
his letter to the state drug controllers.
In yet another
directive, the DCGI has directed all drug manufacturers to submit the
report of self assessment of their units along with self certification
stating that they are complying with GMP/GLP requirement as per Drugs
and Cosmetic Rules, to the State Licensing Authorities and CDSCO by
30.08.2017.
The DCGI office had earlier prepared a detailed
checklist for all manufacturing facilities to comply with the
requirements of Good Manufacturing Practices (GMP) and Good Laboratory
Practices (GLP) as specified under Schedule M and Schedule L-1 of the
Drugs and Cosmetics Act and Rules there under. The checklist includes an
elaborate tool kit for verification of GMP/GLP along with benchmarks
based on the concept of rating manufacturing units on the basis of an
estimated risk that they may pose to users of medicines. This checklist
was devised with a view to ensure that each manufacturing unit carries
out self assessment to GMP/GLP compliance.
All drug manufacturers
and pharmaceutical associations were requested vide notice no.
7-5/2016/misc/041 dated 23.07.2015 to make self assessment of their
manufacturing units as part of their self audit and mandatorily share
their reports with State Licensing Authorities and CDSCO.
However,
COSCO is yet to receive self inspection reports from the manufacturers.
“In view of above, all drug manufacturers are requested to submit the
report of self assessment of their units along with self certification
stating that they are complying with GMP/GLP requirement as per Drugs
and Cosmetic Rules, to the State Licensing Authorities and CDSCO by
30.08.2017,” the DCGI stated.
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