Stricter regulations are on the anvil on branding of drug formulations and to enforce the prohibition on advertising medicines.
The Central Drugs Standard Control Organisation (CDSCO) is considering introducing new rules to stop the industry practice of marketing formulations containing different active ingredients under the same brand name. The regulator feels that such brand promotion would mislead consumers and create confusion regarding the therapeutic use of products.
The CDCSO is also planning to extend the ban on advertisement for prescription drugs to distributors and importers, to make it more enforceable.
What do officials say?
There are instances of drug companies capitalising on popular brands to push volumes and sometimes even fetch higher prices. The government will hold public consultations on the issue soon to take opinion from different stakeholders, an official source said. A “brand extension formulation” which has no underlying similarity with the original brand formulation poses serious safety concerns, the official told FE, on condition of anonymity.
The official said that even though such cases are not common, there are a set of companies which sell their products with different molecules under a popular-selling brand. “These practices are usually seen among sone domestic companies, especially among medium and small-size firms,” the official said.
For instance, there are five products under the brand name Asthakind in the market, of which three – Asthakind (containing bromhexine hydrochloride, guaifenesin, menthol, terbutaline sulfate), Asthakind Pro (levocloperastine fendizoate) and Asthakind-DX (chlorphenamine maleate, dextromethorphan hydrobromide, phenylephrine Hydrochloride) – have different compositions.
What do experts say?
However, experts said that CDSCO’s role is to regulate safety and quality of drugs, and it might not have the institutional capability to evaluate whether a drug name is misleading or not. “The central and state-level drug regulators issue drug manufacturing licenses on the basis of generic name, and the applicable law also requires manufacturers of drugs to declare generic name of the drug on the label in conspicuous manner, and in a larger font size than the brand name. So there are already sufficient checks and balances in the system to prevent common people from being misled by brand extension,” said Anay Shukla, founding partner at Arogya Legal.
The official said that amendments in the Drugs and Cosmetics Rules, 1945 are also under consideration to prohibit pharma companies from advertising prescription-only and potent drugs, including life-saving injectables, antibiotics, oncology, psychotropic substances, hormonal preparations and narcotic drugs.
The advertisement for drugs are regulated under the provision of Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, which is administered by the state governments. The Drugs & Cosmetics Rules, 1945 were amended in 2015 to bring a provision that prevents advertisement of drugs specified in Schedule H, Schedule H1 and Schedule X (or prescription drugs) except with the previous sanction of the central government. But these regulations govern just manufacturers of the medicines. Distributors and sellers of drugs don’t come under its purview, giving them the freedom to advertise.
“Most companies generally don’t cross the line but because of the existing loophole, we have witnessed some instances of advertisement of prescription-only drugs by drug sellers. These amendments will be applicable to them and importers,” the official said.
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