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.
Let the Truth be known. If you read VB and like VB, please be a VB Supporter and Help us deliver the Truth to one and all.
Lebanon appoints new representative for talks with Israel, rejects linkage to Iran
Beirut: Lebanon’s has moved to underline its independent position in ongoing regional developments, amid attempts to link the country to the broader conflict involving Iran, the United States and Israel.
President Joseph Aoun, while announcing the appointment of former US ambassador Simon Karam as Lebanon’s representative in talks with Israel, made it clear that Karam would be the sole representative for Lebanon and that there would be no substitute.
The move comes in response to what the Lebanese officials see as efforts by Iran to tie Lebanon’s situation to the wider regional conflict. Iran had indicated that there would be no ceasefire involving the US, Israel and Iran unless it also included a ceasefire in Lebanon.
Some groups, including Hezbollah and its supporters, had expressed support for linking the situations, citing concerns that the Lebanese government has limited leverage in negotiations with Israel. Lebanon is not formally a party to the conflict, and its army is considered weak.
However, others, including Prime Minister Nawaf Salam, have opposed this approach. They view Iran’s stance as an attempt to influence Lebanon’s internal affairs and see it as undermining the country’s sovereignty.
Officials backing the government’s position say the move is aimed at reaffirming Lebanon’s sovereignty and ensuring that decisions about peace and ceasefire within the country are not dictated externally.
They also see it as a safeguard, so that any breakdown in talks between the US, Israel and Iran does not automatically lead to renewed conflict in Lebanon.
