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Set up ‘office of drugs safety' in DC depts to handle drugs safety issues & post-marketing surveillance: Dr Satheesh Kumar
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Peethaambaran Kunnathoor, Chennai
June 30 , 2015
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A separate entity attached to each drugs control department is necessary
to handle drug safety measures and post-marketing surveillance which
can help the enforcement agencies to monitor adverse drug reactions in a
big way.
So, the Central Drugs Standard Control Organisation
(CDSCO) and the Indian Pharmacopeia Commission (IPC) must look into the
feasibility of this separate wing and direct all state governments to
consider setting up of an ‘office of drugs safety’ (ODS) under their
drugs control administrations to co ordinate all aspects of drugs
safety, opines Dr S Satheesh Kumar, former drugs controller, Kerala.
Taking
the situation of Kerala as example, he pointed out that even though the
state has the highest per capita consumption of drugs, the drugs
control department has till date no dedicated machinery for monitoring
adverse drug reactions. The same situation is prevalent in most of the
states in India. The well educated consumers and traders in Kerala may
form an ideal pool for adverse drug event detection and reporting, he
said.
In a telephonic discussion with Pharmabiz, Dr Sathesh said
as far as the enforcement agency of any state is concerned, the drug
safety and post marketing surveillance is not a priority area for them.
There are chances for banned and defective pharmaceuticals to infiltrate
into the market always through several sources. Relevance for an
exclusive wing to control the presence of such defective products is
very big.
His suggestion is that the ‘office of drugs safety’
should be devoid of all licensing related activities, and headed by a
senior officer, preferably the chief regulator. Members from medical
fraternity and NGOs on health can be incorporated. The ODS shall be
staffed with officials from the enforcement wing.
The ODS can
address public health threats arising out of irrational combinations,
unapproved drugs, drugs with similar names, circumvention of NPPA,
circulation of defective pharmaceutical products and clandestine
networks promoting drugs. It can review the promotion of drugs by print
and electronic media, and combat violations of advertisements. Further,
it can ensure that clinical trials are carried out in compliance to
Schedule Y of the Drugs and Cosmetics Act.
As part of
implementation of ODS, computer aided drugs registration (CADR)
programme is also envisaged. No quantitative or qualitative data is
available with most of the drugs control departments pertaining to the
drugs marketed in the state. Many a time, drugs containing ingredients
approved/unapproved by other state licensing authorities or drugs banned
by the central government do infiltrate into the market unnoticed. In
the absence of any centralised registry, drugs bearing the same and
similar trade name, but having entirely different chemical contents, can
penetrate into any place, which poses threat to public health.
This
lack of accountability has resulted in situations where cases could not
be charged before the courts as the credentials of the drug traders
located outside the state are never available with the department, the
former enforcement officer said.
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