Express Pharma

India needs to assure regulation for domestic drugs

While Indian pharma exports were regulated years ago, the time has come to start a new era for anti-counterfeiting domestic regulation. In a candid conversation, Nakul Pasricha, President, Authentication Solutions Providers Associations (ASPA), reveals more to Akanki Sharma

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How often does the Indian pharma industry face the problem of falsified and sub-standard medicines?
According to a study by the International Institute of Research Against Counterfeit Medicines (IRACM), globally, counterfeiting has been measured as about $200 billion problem in terms of statistics. According to research from WHO study, an estimated one in 10 medical products circulating in low- and middle-income countries is either substandard or falsified. Since 2013, WHO has received 1,500 reports of cases of substandard or falsified products. Of these, antimalarials and antibiotics are the most commonly reported. Prior to 2013, there was no global reporting of this information and this is likely just a small fraction of the total problem and many cases may be going unreported. A regulation by the Director General of Foreign Trade (DGFT) has been there in our country since 2011, according to which all medicines exported out of India must have barcoding.

What are the adverse effects of these kinds of medicines on the economy of the country?
FICCI had done a study in 2015, where it was found that the loss of tax revenue is Rs 40,000 crores (excluding pharma). Unfortunately, the study did not include pharma sector. One way to estimate is that the total Indian pharmaceutical sector valued at US$ 35 billion in 2017. The domestic market of India is $17 billion. Some independent studies have found the rate of sub-standard or spurious drugs to be about seven to 10 percent in India. The country’s pharmaceutical exports stood at US$ 17.27 billion in FY18 and have reached US$ 19.14 billion in FY19.

Are there any laws/policies or guidelines to be followed for fighting this menace? If yes, are these being followed? If not, why?
In 2011, the Union government had said that it needed to protect the reputation of its exports and of the pharmaceutical industry, and they thus implemented segregation for all drugs leaving India. So, customs officials stopped shipments which did not have segregation. So, we are doing a great job of implementing this and protecting the patients around the world, but what about our own citizens? In 2018, the Drugs Technical Advisory Board (DTAB) recommended that top 300 pharma brands in India should have an anti-counterfeiting solution, namely application of a unique code to each consumer-level pack coupled with SMS-based authentication of that code. However, they asked for it to be voluntary and so far, it has not progressed much. They are still committed but since it is voluntary, the adoption is not yet as high as expected. According to sources, for the domestic API market, the Ministry of Health has prepared a draft mandating quick response (QR) codes at each level of packaging of active pharmaceutical ingredients (APIs).

Besides, Interpol has an operation called PANGEA, which in 2018 seized 10 million units of medical devices, including syringes, contact lenses and hearing aids, among others. Its value was $14 million, 859 people were arrested and almost 3,500 websites had gone offline. We feel that there may be certain factors that the pharma industry would like to be addressed to spur adoption of anti-counterfeiting solutions. Nonetheless, there is a way regulators and industry can come together to address these concerns in a productive way, by striking a balance between affordability of medicines on one hand, and quality on the other.

Have you tried to approach the government on this issue?
We have had meetings in the past. The government was positive but acknowledged that some concerns had been raised by pharma companies that needed to be addressed. What we emphasised and continue to emphasise on is that these concerns may be valid, but solutions are available if all stakeholders – regulators, pharma companies, solution providers and consumers – come together as one and resolve to stop the spread of spurious and sub-standard medicines.

Moreover, from a digital solutions perspective, serialisation is something that has emerged as a global standard in the pharmaceutical industry and new GS1 regulations are widespread. From a physical solutions perspective, there are a variety of technologies – tamper-evident, tamper-proof, overt and covert features and as an association, we have created an environment in India where technologies are available and ready for adoption and it’s a question of working together with the industry and the government. From the industry perspective, we are protecting thousands of pharma brands with the help of our 61 members.

Are there any cost-effective anti-counterfeiting solutions available in the market?
There are multiple cost-effective creative solutions that our members are already providing to the pharma industry. In addition, we have been providing digital solutions like barcoding, un