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.