In a bid to tackle spurious drugs menace in the pharmaceutical industry, the Maharashtra FDA joint commissioner Omprakash Sadhwani has emphasised the need for multi-pronged approach including strengthening drugs control organisations, effective networking between the stakeholders as well as creating awareness among consumers about such drugs.
The term spurious drugs is defined under Drugs Act. Broadly speaking it means a drug which does not contain any active medicine or a particular brand/drug is manufactured by unlicensed or a fictitious company. The term counterfeit is not separately defined under Drugs Act. But normally it includes instances of brand copying, trade mark violations, copy right violations, names having phonetic similarity with the leading brand names, he said.
“Concerted efforts from all stakeholders will help curb the counterfeit drugs issue. Any drug entering the supply chain which not from original source needs to be alerted and we want to develop strong co-ordination between industry and FDA through this step to help curb the fake medicine menace. Counterfeit products are not impossible to locate, it is challenging to eradicate it completely and we need industry intelligence networks to be more pro-active in this. Medical representatives, medical practitioners, investigating agencies, non government organisations and associations are source of information about the spurious drugs. Maharashtra FDA has decided to assign its two members to the industry who they can share evidence, exchange information and work together in confidentiality,” Sadhwani said.
He said the pharma industry needs to have network sharing of information on changes in packing/hologram, unusual drop in sales in particular area or of a particular brand, train the medical representative to collect and share information with regulators, unusual incidents such as unauthorized order for preparation of cylinder or printing of foil reported from packing department.
Talking about strengthening the mechanism to deal with counterfeit drugs, Sadhwani stressed on the need to give more powers to drug inspectors, define counterfeit separately, provide protection to innocent dealers, and inbuilt incentives to informants.