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.

Solutions are available if f 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

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 $17 billion. Some independent studies have found the rate of substandard or spurious drugs to be about seven to 10 percent in India. The country's pharmaceutical exports stood at US$ 17.27 billion in FY18 and have reached US$ 19.14 billion in FY19.