Set up ‘office of drugs safety' in DC depts to handle drugs safety issues & post-marketing surveillance: Dr Satheesh Kumar

Peethaambaran Kunnathoor, ChennaiTuesday, June 30, 2015, 08:00 Hrs  [IST]

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.