The central government has directed that medicines containing a combination of Chlorpheniramine Maleate and Phenylephrine Hydrochloride should not be given to children below four years of age, citing safety concerns associated with the drug combination.

The restriction was issued on Saturday following recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB). The government said the measure is intended to protect young children from potential health risks linked to the use of the combination.

The latest order applies to Fixed Dose Combination (FDC) medicines containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride. Pharmaceutical companies will now be required to ensure that these medicines carry a clear warning against their use in children under four.

Warning To Be Displayed

The government has made it mandatory for manufacturers to prominently display the warning on medicine packaging, package inserts and promotional material.

The warning must clearly state that the medicines should not be used in children below four years of age. The requirement is intended to ensure that parents, caregivers and healthcare professionals are aware of the age restriction before the medicines are used.

Experts have raised safety concerns about the use of the combination in very young children, while safer treatment options are available for this age group.

Order Under Drugs Act

The latest directive has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, which allows the government to regulate or restrict the manufacture, sale or distribution of certain medicines when such action is considered necessary in the public interest.

The move follows an earlier government notification issued on April 15, 2025, concerning warnings on certain Fixed Dose Combination medicines.

The latest order expands the age-specific restriction to all FDC medicines containing the Chlorpheniramine Maleate and Phenylephrine Hydrochloride combination for children below four years.

What Are FDC Medicines?

Fixed Dose Combination medicines contain two or more active pharmaceutical ingredients in specific quantities in a single formulation. Such combinations are commonly developed to address multiple symptoms or therapeutic requirements through one medicine.

Under the latest directive, manufacturers of FDC medicines containing the specified combination must comply with the new age-related warning requirements.

The government has also made clear that these medicines should not be used for children under four years of age. Parents and caregivers should check the age-related warnings on medicine packs and consult a qualified healthcare professional before giving medicines to young children.

The restriction comes amid continued regulatory scrutiny of medicines intended for children, particularly combinations used for cold and cough symptoms, where age-appropriate safety remains a key concern.

India imports about 65% of the raw materials needed to make medicines from China, NITI Aayog said Tuesday, warning that heavy dependence on a single country or region leaves the pharmaceutical supply chain vulnerable.

Speaking while releasing the Trade Watch quarterly report, NITI Aayog Vice‑Chairperson Ashok Kumar Lahiri said the “Middle East crisis” has underlined the need to diversify suppliers for critical inputs such as medicines, oil and gas. “We should not depend on one country or region,” he told reporters, adding that India must ensure multiple sources for energy and other essential supplies so crises do not disrupt domestic availability.

The report — which also presents data on India’s overall imports‑exports and energy sector — found that while India is a global leader in producing affordable generic drugs, much of the active pharmaceutical ingredients (APIs) and other chemical inputs still come from China. Officials said the finding supports recent policy discussions on securing supply chains and boosting domestic capability.

Lahiri urged negotiators to include a dedicated pharmaceuticals chapter in any free trade agreement (FTA). “When negotiating FTAs with countries or blocs, a separate chapter on pharmaceutical products should be included,” he said, according to excerpts shared by the Aayog. The recommendation reflects concerns that tariff and non‑tariff provisions must specifically protect and promote India’s pharma value chain.

The report also highlighted rising costs for R&D and manufacturing in India. Stricter environmental rules, Lahiri noted, have pushed up the cost of running production facilities and carrying out research into new drugs. “Environmental regulations have become quite tight. That has increased the cost for companies to produce medicines and pursue new R&D,” he said. The Aayog suggested that India’s system for translating academic research into commercial products needs strengthening to attract long‑term investors.

India’s strength remains production. The Aayog’s study concluded that India performs well on drug manufacturing but needs to move up the value chain — into higher‑margin, branded and innovative products — to capture greater global value. “Indian firms have good international credibility. If they bring high‑quality, reasonably priced branded products, our grip on global markets can strengthen,” Lahiri said.

The report also underlined India’s role as a supplier of affordable generics worldwide: about half of the low‑cost medicines exported from India go to African countries. In 2025, global demand for medicines and inputs was estimated at roughly ₹123.13 lakh crore (about $1.3 trillion), of which about ₹96.61 lakh crore went to finished medicines and roughly ₹24.72 lakh crore to chemicals and raw materials used by drug makers, the Aayog noted.

To reduce dependence on imports and build resilience, the Aayog offered a set of policy suggestions:

• Encourage Indian firms to move beyond generics into high‑value pharmaceutical segments.

• Strengthen links from college and university research to industry so discoveries commercialise faster.

• Make regulatory approvals for life‑sciences innovation clearer, faster and more transparent to draw patient long‑term investment.

• Include pharma‑specific provisions in FTAs and pursue bilateral deals — Lahiri said India and the US are close to finalising a bilateral trade pact and expected to sign it soon.

Experts and industry sources say the challenge is not only policy but capacity and investment. Building API manufacturing at scale requires capital, land, and trained personnel; cleaning up chemical manufacturing to meet environmental norms adds to costs. The Aayog’s recommendations aim to balance ecological compliance with incentives for domestic production.

Further details on timelines, funding packages or specific incentives were not available in the report. Authorities are reviewing follow‑up measures, and officials said more clarity on implementation will be provided as the government consults industry stakeholders.

Why it matters
India’s dependence on China for pharma inputs is a strategic vulnerability for public health and industrial policy. Any disruption — from geopolitical tensions to supply shocks — can affect drug availability and prices at home and for countries that rely on Indian exports. Moving up the value chain would also help India capture higher margins and reduce exposure to external suppliers.

Further details are awaited as policymakers and industry leaders discuss the Aayog’s recommendations and the implications for upcoming trade talks.