The fate of some marquee brands is uncertain as the government phases out codeine-based cough formulations and a handful of fixed-dose combination (FDC) drugs. Some of these brands have been declining anyway, analysis shows.

Industry insiders say that pharma companies working with codeine-based cough formulations are implementing steps to prevent misuse. Codeine is a by-product of opium, which is processed in India under strict terms. In July, the government for the first time allowed a private company, Bajaj Healthcare, to process opium to extract alkaloids that are used to make painkillers, cough syrups, and even cancer drugs. Two government factories in Uttar Pradesh and Madhya Pradesh process around 800 tonnes per annum of opium gum to extract alkaloids. But Bajaj Healthcare will process the opium and give it back to the government, which would then sell it to the industry.

However, the problem begins after codeine-based products enter the market. The Narcotics Control Bureau (NCB) recently arrested a group for smuggling drugs between Uttar Pradesh and Mumbai, recovering 13,248 bottles of codeine-based cough syrup.

Pharma firms are improving traceability to check cough syrups reaching drug rackets in bulk quantities. “We have started QR code tracing. We have also reduced the batch sizes that we send out to trade – almost half the size of other liquid drugs. This enables closer tracking of the products,” said the chief executive officer of a pharma company who requested anonymity.Another Mumbai based manufacturer of codeine based cough syrups said that steps are being taken to account for each bottle of the cough syrups sold. “This is done right from the stockist level to the chemist level.

They have to maintain records of selling each codeine based cough syrup. Unless they account for it, they are not allotted fresh stocks. This makes the movement of the drugs slow in the system, but this is adopted as a failsafe,” he explained.

Spurious codeine-based products have flooded the market and QR codes reduce the menace, according to the industry. The Indian Drug Manufacturers Association (IDMA) has reached out to the government, requesting it to not ban codeine-based cough syrups.

IDMA secretary general Daara Patel said the government should not take any such action because such drugs are clinically safe.

Data from market research firm AWACS shows that sales of Phensedyl cough linctus (Abbott brand) has reduced from Rs 304.9 crore in 2018 to Rs 66.3 crore now. Phensedyl T, another brand extension, has however seen moderate growth—from Rs 7 crore to Rs 10 crore—in the same period. However, Pfizer’s Corex T sales have doubled during the period. (see chart).

On the other hand, some key FDC drugs have seen moderate growth. Ipca’s pain relief medicine Zerodol SP, however, has seen strong growth in recent years.

A Mumbai-based analyst said that companies have not launched new drugs as fixed-dose combinations in recent years. “After the Centre banned 343 FDCs in 2018, most pharma companies have stayed away from launching new FDCs, unless they were brand extensions of their popular brands. There is always this sword hanging over this class of drugs,” he said, adding that Ipca is likely to be hit the most if FDCs are phased out.

“The current FDCs, which are under scanner, belong to the first category, that is either they are for cough treatment or the treatment of body ache or cold. Such FDCs can definitely be revoked because these FDCs are not approved in other parts of the world. They are specifically approved in India and some of them definitely fall under irrational combinations,” said Arvind Badiger, technical director, BDR Pharmaceuticals.