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IPC to organise workshops on 'pharmacovigilance guidelines' in Chennai & Pondicherry on Nov 10 and 11
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Peethaambaran Kunnathoor, Chennai
November 10 , 2017
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With an aim to sensitize the manufacturers of pharmaceutical products in
India about the guidelines on pharmacovigilance released by the Drugs
Controller General of India (DCGI) in July this year, the Indian
Pharmacopoeia Commission (IPC) is gearing up to train the manufacturers
on how to implement it and how they can benefit out of it.
The
guidelines will become effective from January 2018 and all the
manufacturing and marketing companies need to follow the rules. As part
of compliance, from next year every company, whether it is big or small,
should have a pharmacovigilance monitoring cell for post marketing
surveillance of their products.
In Tamil Nadu, to train the
manufacturers, the IPC, along with TN IPA, is organizing two days
training program, one in Chennai and another one in Pondicherry, on
November 10 and 11 respectively. Senior officers from the IPC will speak
to the company leaders and sensitize them about the guidelines and how
they are benefited, said Dr. V Kalaiselvan, principal scientific officer
at the IPC.
J Jayaseelan, chairman of TN IPA, said since it is
mandatory for all manufacturing units, the companies will set up
post-marketing surveillance mechanism to monitor the side effects of
their products. Welcoming the initiative taken by the DCGI to sensitize
the industry, he said all the companies are getting prepared to make
tacking mechanism in their units and TN IPA is supporting the system.
With this, all the manufacturers need to monitor the side effects of
their products after they are put for marketing.
According to
him, the strip of the drugs will contain the contact details of the
surveillance cell with email id and a toll-free number. The company will
track side effects, if any reported, and take necessary action.
The
director of Tamil Nadu drugs control department, S Sivabalan, said in
support of the public health initiative introduced by the DCGI, the
state regulators will check if all the manufacturers and marketers
follow the guidelines properly.
All the marketing companies will
be mandated to set up pharmacovigilance cell once the guidelines are in
effect. The marketers can meet their pharmacovigilance obligations
either by setting up in-house systems for monitoring or can enter into
contractual arrangements with manufacturing companies.
In Chennai
the program will be held at Hotel Deccan Plaza at Royapetta from 6 pm
onwards on Friday, and in Pondicherry it will be held at Hotel Annamalai
International at Saram from 10 am onwards on Saturday.
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