Roger Williams, CEO of the United States Pharmacopeia (USP) says, “In countries like India and China, which are centres for the manufacture of medicines and ingredients, it is inevitable that some of them are counterfeits. The US market is driven by generics where Indian pharmaceutical companies have been playing a key role. India needs strong drug standards.” USP is working closely with the FDA to help ensure the quality of medicines and its role is to set standards for the identity, purity, strength and quality of medicines and FDA participates in this standards-setting process. However, USP plays no role in enforcement of these quality standards, which in the US is the sole responsibility of FDA.

Recently, USP rolled out a new public database listing quality measures on drugs sampled around the world. The resource, launched with backing from the FDA, lists authenticity testing results for 8,700 drug samples to date, including key anti-malarials and anti-tuberculosis medications obtained from pharmacies and clinics worldwide. The database is freely accessible online, and contains critical quality data such as the time and location of drug sampling. With the new database, countries will be able to identify which drugs are being counterfeited in neighbouring countries and be alerted of products of concern. USP and FDA are also developing use of hand-held instruments for law enforcement inspectors to test drug quality in the field.

Generally speaking, all kinds of medicines are counterfeited—branded and generic—ranging from medicines for the treatment of life-threatening conditions to inexpensive generic versions of painkillers and antihistamines. The complexity of the distribution network is the principal point from where counterfeit drugs make their way into the pharmaceutical chain. Once a product leaves the company, a number of players like wholesalers and brokers get their hands on the drugs consignment. The danger snakes its way into the pharmaceutical chain soon after the product leaves the four walls of a company. With a number of wholesalers and brokers getting their hands on the drugs consignment, it is difficult to identify exactly when the process starts to take an ugly turn. The low likelihood of detection is an added incentive. “The economic motivation to counterfeit certain medicines can be powerful, especially given the low costs and low likelihood of detection or punishment in many countries,” Williams explains.

Sample some recent fake drug seizures in India: enforcement agencies carried out raids at central Delhi’s medical wholesale market, Bhagirath Place, and subsequently also in Agra, and busted an organised gang selling spurious drugs and those meant for Central Government Health Services (CGHS), Municipal Corporation of Delhi (MCD) and even the Director-General of Armed Forces Medical Services (DGAFMS). Drugs worth R40 lakh were seized in both the cities. Bejon Mishra, founder, Partnership for Safe Medicines India says that the existing laws in India are adequate to deal with counterfeiters. The Drugs and Cosmetics Act has been amended to provide for stricter penalties for offences particularly to those engaged in making of spurious, adulterated, misbranded and substandard drugs. The maximum penalty has gone up to life imprisonment and fine of R10 lakh or three times the value of confiscated goods, whichever is more. “But it is high time all the stakeholders agree to work on this challenge to protect patient’s right and public health. While spurious medicine sales are difficult to quantify and track, it would be foolhardy to ignore their trail of damage and death,” he laments.

Ranjit Shahani, vice-chairman & managing director, Novartis India, has also strongly canvassed for deterrent legislation against counterfeit drugs. “It is a rather arduous task to estimate the true penetration of counterfeit drugs. Trade in counterfeit drugs is widespread and affects both developing and developed countries. All medicines are subject to counterfeiting, both branded and generic.” The pharmaceutical industry has looked at various measures to prevent counterfeiting including innovative packaging, bar coding and RFID. “Product serialisation, that is, a unique ID code attached to each saleable item, combined with consumer verification ability of that code via SMS or internet is the state-of-the-art. Perhaps, this technology can empower consumers themselves to check the authenticity of their medicines,” he adds.

From IT companies’ perspective, S Suryamohan, head of life sciences solutions, Mahindra Satyam feels that lack of ownership and integrity in the pharmaceutical supply chain is leading to dented brand value, adulterated or diverted prescription drugs. This is having a big impact on brand value and cost of recalls. The company has launched its new offering, ‘Serial xPress’. When implemented across the supply chain and used effectively, serialisation and electronic pedigree can bring in supply chain optimisation, reduced product recalls in addition to anti-counterfeiting and enhanced brand value.

J Sairamkumar, vice-president, life sciences practice, Cognizant says that counterfeiting of medicines is a concern that affects the end consumer safety as well as the image of the industry. With state governments starting to mandate implementing anti-counterfeiting measures, there is a much stronger commitment now from the industry. The intent to tackle the problem of counterfeiting is high with pharmaceutical companies but they do not necessarily have the technological expertise for developing solutions which lies with the IT companies. Thus, effective partnership between IT and pharmaceutical companies is essential to tackle the problem of counterfeit medicines, says Anjan Sen, director (strategy and operations) Deloitte in India.

While the world has adopted stringent measures to fight counterfeit drugs, it’s time India showed some resolve to arrest this menace.