Drug controllers urged to ensure testing of pharma products before releasing them in market
New Delhi (PTI): The Drugs Controller General of India (DCGI) has urged all drug controllers of the states and Union Territories to ensure testing of raw materials and finished formulations of pharmaceutical products before releasing them in the market in the wake of children's deaths allegedly due to the consumption of contaminated cough syrup in Madhya Pradesh and Rajasthan.
Five children from Madhya Pradesh are in a critical condition, while 20 have died due to kidney infections caused by the consumption of the "contaminated" cough syrup, containing Diethylene Glycol (DEG) and Ethylene Glycol (EG).
Besides, at least three children have allegedly died in Rajasthan after consuming cough syrup in different districts of the state.
In an advisory, the DCGI said that during recent inspections at manufacturing facilities and in the investigations of the drugs declared as 'Not of Standard Quality', it was found that several manufacturers are not testing each batch of excipients and active ingredients for compliance with prescribed standards before use.
The DCGI said that the directorate has, from time to time, emphasised the critical importance of testing of raw materials, including the excipients, before their use in the manufacturing of pharmaceutical formulations.
There have been recent reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups and concerns related to the quality of these cough syrups, the advisory said.
"During the inspections carried out at the manufacturing facilities and in the investigations of the drugs declared as Not of Standard Quality, it was observed in the reports that the manufacturers are not carrying out testing of each batch of the excipients/inactive and active pharmaceutical ingredients for verification of compliance with the prescribed standards before using them in the manufacture of formulations and also in the finished products," the advisory dated October 7 said.
The advisory highlighted that according to Drugs Rules, including rule 74 (c) and rule 78 (c) (ii), the licensee shall, either in his own laboratory or in any laboratory approved by the licensing authority, test each batch or lot of the raw material used by him for the manufacture of his product and also each batch of the final product, and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U.
"All the State/ UT Drug Controllers are requested to take measures to ensure testing before the manufacture and release of the batch to the market by way of monitoring during inspections, sensitising the manufacturers through circulars, etc.
"Further, it shall also be ensured that the manufacturers have a robust vendor qualification system in place and use raw materials, including excipients, from reliable approved vendors only," the advisory said.
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India proposes preferential trade agreement with Mexico to deal with high tariffs
New Delhi (PTI): India has proposed a preferential trade agreement (PTA) with Mexico to help domestic exporters deal with the steep tariffs announced by the South American country, a top government official said on Monday.
Mexico has decided to impose steep import tariffs - ranging from about 5 per cent to as high as 50 per cent on a wide range of goods (about 1,463 tariff lines) from countries that do not have free trade agreements with Mexico, including India, China, South Korea, Thailand and Indonesia.
Commerce Secretary Rajesh Agrawal said that India has engaged with the country on the issue.
"Technical level talks are on...The only fast way forward is to try to get a preferential trade agreement (PTA) because an FTA (free trade agreement) will take a lot of time. So we are trying to see what can be a good way forward," he told reporters here.
While in an FTA two trading partners either significantly reduce or eliminate import duties on maximum number of goods traded between them, in a PTA, duties are cut or removed on a limited number of products.
Trading partners of Mexico cannot file a compliant against the decision on imposing high tariffs as they are WTO (World Trade Organisation) compatible.
The duties are within their bound rates, he said, adding that their primary target was not India.
"We have proposed a PTA because its a WTO-compatible way forward... we can do a PTA and try to get concessions that are required for Indian supply chains and similarly offer them concessions where they have export interests in India," Agrawal said.
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Citing support for local production and correction of trade imbalances, Mexico has approved an increase in MFN (most favoured nation) import tariffs (5-50 per cent) with effect from January 1, 2026 on 1,455 tariff lines (or product categories) within the WTO framework, targeting non-FTA partners.
Preliminary estimates suggest that this affects India's around USD 2 billion exports to Mexico particularly -- automobile, two-wheelers, auto parts, textiles, iron and steel, plastics, leather and footwear.
The measure is also aimed at curbing Chinese imports.
India-Mexico merchandise trade totalled USD 8.74 billion in 2024, with exports USD 5.73 billion, imports USD 3.01 billion, and a trade surplus of USD 2.72 billion.
The government has been continuously and comprehensively assessing Mexico's tariff revisions since the issue emerged, engaging stakeholders, safeguarding the interests of Indian exporters, and pursuing constructive dialogue to ensure a stable trade environment benefiting businesses and consumers in both countries.
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Federation of Indian Export Organisations (FIEO) Director General Ajay Sahai has said that Mexico's decision is a matter of concern, particularly for sectors like automobiles and auto components, machinery, electrical and electronics, organic chemicals, pharmaceuticals, textiles, and plastics.
"Such steep duties will erode our competitiveness and risk, disrupting supply chains that have taken years to develop," Sahai said, adding that this development also underlines the little urgency for India and Mexico to fast-track a comprehensive trade agreement.
Domestic auto component manufacturers will face enhanced cost pressures with Mexico hiking duties on Indian imports, according to industry body ACMA.
