Will regulators catch up in 2020?

The industry will always find ways to slip through legal loopholes. Will regulators catch up in 2020?

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The last month of 2019 was marked by debate on three important issues and all are awaiting long pending regulation: online pharmacies, pharma marketing practices and defining supplements versus medicines. Regulation in all the three areas could herald major changes to India Pharma Inc.

On November 28, an order from DCG(I) VG Somani, directing all states and Union Territories to prohibit the sale of medicines through unlicensed online platforms till draft rules to regulate e-pharmacies are finalised and put in place, stirred up the debate once more.

The past year has seen an evolution of the e-pharmacy business model, with the two sides in tacit cooperation. For the offline part of the business, e-pharmacies have empanelled traditional pharmacies, with registered pharmacists verifying e-prescriptions before fulfilling orders. Many offline pharmacies are experiencing the benefits of becoming empanelled with – or going the franchisee route – with e-pharmacy chains as they get better inventory control as well as extended customer reach.

Quite predictably, the lack of policy has not dulled the sheen of the e-pharmacy sector. According to industry estimates, the sector has received funding of over $700 million from private equity and venture capital. A sector update from Motilal Oswal Institutional Equities estimates that the size of the e-pharmacy sector is expected to increase to Rs 250 billion by 2022 compared to just Rs 3.5 billion in 2018.
Though e-pharmacies currently account for just three per cent of the overall pharma market in India, their share is expected to increase. Increased Internet usage, an aging demographic (the 50+ age group is expected to increase 26 per cent by 2035 versus 18 per cent in 2015) leading to a shift from acute to chronic ailments is expected to drive more patients to shop online for medication.

This is precisely why regulators are being so careful. While the benefits of online pharmacies for pharma companies are a given, in terms of better inventory control and market insights, it is the patient/consumer who needs to be protected from counterfeit medicines entering the supply chain
as well as harmful overuse of certain categories
like antibiotics.

The debate on pharma marketing practices was revived by a report by Dr Arun Gadre and Dr Archana Diwate of Support for Advocacy and Training to Health Initiatives (SATHI). Published in August, the authors reviewed the ‘Practices of the Pharmaceutical Industry and Implementation Status of Related Regulatory Codes in India’ and give ample evidence that regulation has failed to curb unethical promotional practices. Though the study is qualitative in nature, based primarily on 50 in-depth interviews with mainly medical representatives, in six selected cities across the country, the authors present enough examples to justify their conclusion that when even mandatory Medical Council of India regulatory codes are not being enforced, voluntary codes like the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) remain only on paper.

For instance, the authors detail the role of Propaganda Cum Distribution Companies (PCDs), which are franchisees of pharma manufacturing companies, which buy drugs in bulk from the manufacturers, give their own brand name and directly sell them to retailers and doctors, at huge discounts and incentives (gifts/cash/hospitality/travel facilities etc.).

The regulators are showing some signs of cracking down on the third issue: pharma companies tweaking their formulations to get them licensed as foods under the Food Safety and Standards Act, 2006 by the Food Safety and Standards Authority of India (FSSAI). This is to escape price control and higher scrutiny under the Central Drugs Standard Control Organisation(CDSCO).

For instance, the FSSAI was alerted by the CDSCO that various brands of methylcobalamin were being manufactured and sold under the FSSAI. The CDSCO pointed out that only two variants of vitamin B12, cyanocobalamin and hydroxycobalamin were covered under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary use, Food for Special Medical Purpose, Functional Food and Novel Food) regulation 2016 which did not cover methylcobalamin. On October 31, the FSSAI ordered a surveillance drive against such manufacturers based on the CDSCO’s alert.

Let’s hope 2020 and the decade ahead see the harmonious resolution of debates like the three issues outlined above.

CDSCOIndian drug regulationsSupport for Advocacy and Training to Health Initiatives
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