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Indian pharma needs to adopt unique labelling options to detect & stall fake drug sale: Dr. Piyush Gupta

Nandita Vijay, Bengaluru
Friday, September 8, 2017, 08:00 Hrs  [IST]

Indian pharma industry needs to adopt unique labelling options to detect and stall fake drug sale, said Dr Piyush Gupta, Associate Director, GNH India.

Customers need to be aware that counterfeit drugs are available and to look out for distinguishing and unique labelling to separate the fake drugs from the real ones. This is the last line of defence against fake generic drugs, Dr Gupta told Pharmabiz.

The industry must comply with all guidelines of  World Health Organization including  Good Manufacturing Processes (GMP), Good Distributions Practices (GDP) and making sure that all generics have a unified and equivalent standard to the innovator drug. Pharma companies must be compelled to stringently adhere to these standards and avoid public health hazards. Monetary fines and penalties can be looked as an option. Unique labelling is also an opportunity  that companies can explore, he added.

In some companies not just in India but globally too, for the generic drug development, bio-availability & bio-equivalent studies in comparison to the innovator are seen to be  bypassed to save cost. This has led to a consistent fall in drug efficacy. Since the last few years the Stringent Regulatory Authorities (SRAs) of various countries insist for  proof of manufacturing to ensure that the highest standards of manufacture, distribution and storage have been met. This move has caught several manufacturers off guard, stated Dr. Gupta.

In an attempt to be economical, many manufacturers do not spend adequately on Innovators and Reference Listed Drug (RLD). Now RLD is an approved drug product to which new generic versions are compared to show that they are bioequivalent. Usually a period of 12-18 months for clinical trials is mandatory to ensure that all manufactured drugs meet a certain standard.  But by cutting corners and taking a shorter route, the companies land up paying a lot more in terms of medicines recalls and unusable stock. This has also resulted in a serious blow to their reputation by selling and distributing medicines that are a public hazard, he said.

GNH India is a global source for priority medicines. The company has aided sourcing of medicines from the small countries like Taiwan to global giants like the US. It supplies RLDs on a weekly basis or as per the demand surges. It also provides a pedigree dossier as recommend by the WHO, so that this premium paid for RLD is well worth it for manufacturers. With the help of the pedigree dossier the RLDs can be used to launch products in any regulated market or WHO pre-qualification process etc. It  confirms the quality standards of the drug. Therefore Indian pharma industry needs to adopt unique labelling options to detect and  stall fake drug sale, said Dr. Gupta.


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dino Sep 22, 2017 5:08 PM
It is with pleasure, to announce that we at Validactor have decided to offer totally free anti-counterfeiting solutions to drug manufacturers. The plague of fake drugs is horrible and we want to do our part to stop it. More info on www.my-validactor.com
Raman Kalia Sep 9, 2017 9:20 AM
Well covered article that talks about need of the hour. It is time that companies understand the responsibility to their consumers bringing up safeguards against counterfeiting. There is also a world of opportunity of connecting directly with consumers, ranking feedback and making cross and upsell of products to them with the help of unique labeling that can be verified in real-time.
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