Cough syrup makers see healthy future, say controversies won't dent demand

For the past two-and-a-half years, India’s Rs 5,400-crore cough syrup market has been front and centre of public attention, not always in a positive way. The outbreak of the Covid-19 pandemic saw cough syrup sales jump, with the characteristic dry cough being a common after-effect of the virus. At the same time, the government has been deliberating on a ban on codeine-based cough syrups, a move that has added uncertainty to the future of a Rs 438-crore segment of the market. Finally, with the recent deaths of 66 children in The Gambia linked to India-made cough syrups many questions have been raised on the state of pharma regulatory bodies in India.

The pharma industry, however, does not think that these controversies will cause a cutback in cough syrup sales in the medium to long term.

“We are one of the top generic drug manufacturers in the world, and ‘one off’ cases have not impacted long-term prospects. Cough syrup demand is unlikely to be dented,” said Daara Patel, secretary-general of the Indian Drug Manufacturers’ Association (IDMA). Patel is also part of the industry representation made to the Centre on the matter of codeine-based cough syrups. The government’s concerns over codeine is that it is potentially addictive, which is why such syrups can only be sold under medical prescriptions. IDMA has requested the Centre to consider not banning codeine, which they claim is one of the best antitussives (cold suppressants) available today.

At the end of September, the Drugs Technical Advisory Board (DTAB) recommended a ban on codeine-based formulations, and now the country’s drug regulator would take the final call on the matter.

At present, codeine formulations contribute around 8 per cent of the total cough and cold market, said Sheetal Sapale, president-marketing, AWACS, a research and analytics firm. She added that a ban on codeine preparations will lead to an impact of around Rs 43 crore to this market. Many of the top players like Abbott, Mankind, Glenmark, Pfizer and Dr Reddy’s Laboratories have brands in this market.

Data from AWACS shows that cough syrup sales have been growing steadily in the past few years — from Rs 3,861 crore in September 2018 to Rs 5,403 crore in September 2022 (this is moving annual turnover data). In 2022, the overall cough syrups market clocked a 17 per cent growth over the previous year.

The codeine-based cough syrups market, however, has not been growing thanks to the overhang of a possible ban. It has declined from Rs 510 crore in September 2020 (MAT) to Rs 438 crore in September 2022.

Codeine is a by-product of opium, which is processed in India under strict terms. Codeine-based formulations are under the scanner for misuse as a narcotic product. Several smuggling rackets have been busted and codeine formulations (cough syrups mostly) seized. Many people misuse this medication (which is an opioid product) to get intoxicated.

Consignments of spurious cough syrups of popular brands such as Abbott’s Phensedyl have been caught by the Narcotics Control Bureau. Phensedyl sales have declined over the years — from Rs 295 crore in September 2018 to Rs 77 crore now.

As for the case of poisoning due to contaminants in the cough syrup, industry insiders point to supply chain issues.

Though allegations against Haryana’s Maiden Pharmaceuticals are yet to be officially proven, India’s national drug regulator and Haryana’s drug controller have halted production at its Sonipat site last week. As the scare of “killer” cough syrups spread, the state food and drug commissioners jumped into action and are testing samples from across brands to identify any contamination. Maiden Pharma is under fire after the World Health Organization (WHO) last week raised red flags connecting cough syrups produced at Sonipat to the deaths of 66 children in The Gambia.

Drug authorities said that Maiden Pharma has not carried out quality testing of propylene glycol, an ingredient used in cough syrups. Inspections found batch numbers, expiry or manufacturing dates and name of manufacturer missing from invoices of propylene glycol.

Pharma industry insiders claimed that most contamination-related problems arise due to solvents. “These solvents are not only sold to the pharmaceutical industry, but to chemical industries and even textiles. At times, solvents unfit for human consumption make their way into the pharma supply chain. The manufacturer needs to have robust quality assurance and control systems in place to pick this up,” said a senior executive of an Ahmedabad-based firm.

A state Food and Drugs Administration (FDA) commissioner said, requesting anonymity, that apart from the producing states such as Maharashtra and Gujarat, most state FDAs do not have the capacities for auditing the facilities in their jurisdiction. “Haryana is not really a pharma hub. The regulator may have audited during grant of licence, but periodic audits have not happened. We usually do random sample tests from the market and if anything is found sub-standard, the facility of the manufacturer is immediately audited,” the commissioner said, adding that in this case, however, the Maiden Pharma cough syrups were not sold in India.

Leena Menghaney, lawyer and India head and global IP advisor of Médecins Sans Frontières – Access Campaign, said that India’s fragmented regulatory system is a major challenge for procurers and quality assurance.

She added that the Central Drugs Standard Control Organisation has a dossier approach for each drug when it approves a new drug at the central level. However, when a drug becomes older, more than four years or so, any manufacturer can seek a licence from the state regulator to manufacture it. “In this case, no dossier approach is followed,” Menghaney claimed. She added that the manufacturers change the source of the active pharmaceutical ingredients (APIs) or even excipients (the substance formulated alongside the API) and these important changes are not necessarily reported to the state regulator.

However, given the demand for popular medicines such as cough syrups, which are often available over the counter, controversies are unlikely to dent sales any time soon.