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DTAB approves DCC recommendations for uniform implementation of provisions of D&C Act and Rules throughout the country
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Ramesh Shankar, Mumbai
June 30 , 2017
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The Drugs Technical Advisory Board (DTAB), the highest decision making
body under the Union health ministry on technical matters, in its 77th
meeting held on June 16, 2017 has agreed with the recommendations of the
Drugs Consultative Committee (DCC) on measures for uniform
implementation of provisions of Drugs & Cosmetics Act and Rules
throughout the country and for strengthening drug regulatory system in
the country.
The major recommendations of the DCC include cadre
restructuring in state drugs control departments for uniform
implementation of provisions of the Drugs and Cosmetics Act, 1940 and
Rules, 1945. As per the recommendation, the post of Drugs Inspectors
should be re-designated as Drugs Control Officers; the grade pay of
Drugs Inspector should be raised to Rs. 5,400 in Pay Band-2; the grade pay of Assistant Drugs Inspector should be raised to Rs. 4,800 in Pay Band-2; and all the other higher posts should accordingly be re-organized.
As
per the DCC recommendation, the Central government should issue
direction to the State governments to ensure adequate regulatory
officials which will be commensurate with the number of sale outlets and
manufacturing units located in the respective States considering that
there should be one official for every 200 sale outlets and one official
for every 50 manufacturing units. There should be provisions for
deputation of State regulatory officials to the Central regulatory
system and vice versa. The minimum experience for Licensing Authorities
(LA) relating to manufacturing and sale of drugs should be raised
adequately.
The DDC had further recommended that the practice of
having multiple LA in a State for regulation of manufacture of drugs may
be replaced by a single LA with provision for delegation of powers to
other regulatory officials. Guidelines, directions as and when issued,
should be communicated to the State government and not to the State
Drugs Controllers for ensuring effective uniform implementations of such
guidelines directions. It was suggested that Drugs Control Authority of
each State should create an Intelligence cell with a Nodal Officer for
market surveillance and conducting investigation in respect of spurious,
adulterated drugs in coordination with CDSCO.
The DCC further
recommended that the drugs samples from supply chain of procurement
agencies needs focused monitoring for ensuring quality of the drugs. The
procurement agencies get their sample tested at approved private drug
testing laboratories and obtain test reports in Form 39, which is
supposed to be issued by such laboratories only to drug manufacturers
who do not have testing facilities. The Drugs and Cosmetics Rules, 1945
should be amended to prescribe a separate Form for issuing test reports
by such laboratories for procurement agencies. The committee while
appreciating the recently conducted National Drugs Survey, mentioned
that a system should be put in place to address issue, if any, relating
to the Survey, when brought to the notice of the authority.
Guidelines
should be prepared for disposal of expired drugs - a committee
comprising Drugs Controllers of Telangana, MP and DOC (I), Hyderabad
zone should be constituted in this regard. Weak areas of market
identified on the basis of risk analysis and intelligence information
shall be kept under active quality surveillance of GAP by conducting
special operations. Regulatory officials should not participate in the
procurement activities as there may be conflict of interest.
Minutes
of all DCC and DTAB meetings held so far should be compiled and
uploaded in CDSCO website. The Medical Device officers to be appointed
under the Rules should have B. Pharm/M. Pharm. Such officer should
undergo training in medical device regulation under a training module
being developed under joint collaboration between Delhi Pharmaceutical
Science and Research University and IPC, Ghaziabad or any other
institutions which deems fit for such activity. Uniform nomenclature on
the pattern of earlier proposal of naming CDSCO as Indian Drug
Administration. Likewise, in the States whether they may be named as IDA
(Name of the State/FDA/name of the institution), the DCC further
recommended.
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