India Inspects 90% Of Cough Syrup Makers After Safety Lapses

India’s drug regulator has intensified scrutiny of cough syrup manufacturers after safety lapses were linked to child deaths in India and overseas markets.

The inspection drive follows the search for contaminated cough syrup that raised concerns over manufacturing practices, raw material testing and quality controls across small and mid-sized producers.

The regulator said it is addressing deep-rooted compliance failures in cough syrup manufacturing. The push comes at a time when India’s pharmaceutical industry is facing reputational damage after repeated safety incidents linked to exported syrups.

The sector is valued at $42 billion and is dominated by smaller manufacturers, making enforcement more complex.

What Did Inspections Reveal?

Nearly the entire cough syrup manufacturing base has been covered under the inspection drive, with widespread lapses found across plants.

Key findings from the inspections include:

• Around 90% of cough syrup makers, or about 1,100 units, have been inspected.

• Several units were found to have breached good manufacturing practices.

• Some manufacturers failed to test incoming raw materials.

• Invalid or unsafe manufacturing processes were detected at multiple facilities.

• An additional 1,250 drug manufacturing units were inspected protectively to assess broader risk.

The inspections followed the discovery of cough syrup contaminated with diethylene glycol that was linked to the deaths of 24 children in October last year. Serious actions were taken where non-compliances were found. However, it has not been disclosed yet how many units were forced to halt operations or faced penalties.

Efforts are underway to fix systemic issues in cough syrup production; however, there is no completion timeline provided. The inspection drive reflects tighter enforcement after India-made syrups were linked to more than 140 child deaths in Africa and Central Asia since 2022.

How Is The Regulator Tightening Oversight?

The regulator is working to upgrade its oversight system according to the global regulatory standards. The aim is to enhance staffing capabilities while decreasing the time needed for approvals and boosting its technical resources.

Key steps under the overhaul include:

• Creating 1,500 regulatory positions with 40% flexible contracts on offer.

• Getting expertise from global industry professionals to strengthen technical reviews.

• Piloting the use of artificial intelligence to screen and review applications.

• Simplifying export approvals by eliminating no-objection certificates for shipments to heavily controlled markets.

The changes could create better enforcement practices while eliminating delays that occur during regulatory approval processes. The regulator has also stated that the reforms will enhance compliance in export-oriented units, which have faced international scrutiny due to quality control failures.

Also Read - GST Cuts, Softer Inflation Set To Boost Consumer Goods Demand

Key Investor Takeaway

The inspection programme could result in stricter regulatory enforcement, increasing compliance costs for all pharmaceutical firms, particularly for smaller enterprises that lack quality control systems.

Stronger monitoring procedures can help the Indian drug export industry regain its confidence. This may threaten the market due to the ongoing production halts and enforcement measures against noncompliant companies.

Considering that weaker enterprises are subject to harsher enforcement, will businesses with better quality controls increase their market share?

Sources:

The Hindu

Economic Times