Antacid, Pan-D, Paracetamol among 50 medications which failed quality test
New Delhi: In a recent and concerning development, India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has flagged over fifty medications, including treatments for diabetes, high blood pressure, and bacterial infections, as not meeting quality standards. The alert issued for August designates these drugs as "Not of Standard Quality" (NSQ), raising alarms about the safety of widely used medications.
Among the drugs failing to meet quality benchmarks are some from leading pharmaceutical companies like Alkem Laboratories, Hetero Drugs, Hindustan Antibiotics Limited (HAL), and Karnataka Antibiotics and Pharmaceuticals Ltd. Notably, the list includes Glimepiride, an anti-diabetic medication; 500 mg paracetamol tablets; Telma H (Telmisartan), used for treating high blood pressure and acid reflux; and calcium supplements Shelcal C and D3.
Shelcal, a calcium supplement produced by Pure & Cure Healthcare in Uttarakhand and distributed by Torrent Pharmaceuticals, was flagged as NSQ. Similarly, Metronidazole, a commonly used antibiotic produced by HAL, failed to pass quality standards.
The scrutiny extends to Clavam 625 and Pan D, low-strength antibiotics manufactured by Alkem Health Science, which were found to be substandard by a state-run laboratory in Kolkata. The laboratory also identified Cepodem XP 50 dry suspension, a pediatric antibiotic from Hetero Drugs, as not meeting the required quality criteria.
Sun Pharma Laboratories Ltd. also came under the spotlight after its Ursocol 300, a medication used to dissolve certain gallstones, was identified as potentially spurious. Karnataka Antibiotics & Pharmaceuticals Ltd.’s paracetamol tablets, widely used for pain and fever, were also flagged for quality issues. Additionally, multiple batches of Telmisartan, a blood pressure medication manufactured by Life Max Cancer Lab in Haridwar, failed quality control tests.
The CDSCO issued two reports highlighting these quality concerns. One report lists 48 drugs that failed to meet quality standards, while the other contains responses from the implicated pharmaceutical companies. Several manufacturers, including Sun Pharma and Glenmark, have denied producing the flagged batches, suggesting the possibility of counterfeit drugs being involved.
Sun Pharma faced further scrutiny after three of its drugs—Pulmosil (used for erectile dysfunction), Pantocid (used for acid reflux), and Ursocol 300 (used for gallstones)—failed quality checks. Glenmark’s hypertension medication Telma H (Telmisartan) and Macleods Pharma’s arthritis treatment Defcort 6 were also implicated. However, all three companies have distanced themselves from the flagged batches, again raising concerns about counterfeit drugs in circulation.
These findings were detailed in the latest non-standard quality (NSQ) alerts issued by the CDSCO. The alerts are based on random monthly tests conducted by state drug authorities as part of ongoing efforts to ensure the safety of medications in the market.
In a related move, the CDSCO has recently banned over 156 fixed-dose combinations (FDCs), citing potential risks to human health. This ban includes popular medications like Cheston Cold and Foracet, which are commonly used for treating fever, pain, and allergies. Since 2014, the regulator has banned a total of 499 FDCs, as part of its ongoing efforts to address safety concerns surrounding multi-drug formulations.
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CM Siddaramaiah alleges ‘criminal conspiracy’ in Sringeri recount, vows legal action
Bengaluru (PTI): Alleging a “criminal conspiracy” by BJP candidate D N Jeevaraj in the Sringeri Assembly poll recounting, Karnataka CM Siddaramaiah on Tuesday said the outcome was manipulated after valid postal ballot votes in favour of Congress leader T D Raje Gowda were tampered with during the recounting process.
Following a Karnataka High Court order on an election petition filed by Jeevaraj, challenging Raje Gowda’s election, the reverification and recounting were conducted on Saturday.
After the reverification and recount of postal ballots for the Sringeri Assembly constituency, votes polled in favour of Raje Gowda were reduced by 255, the returning officer said.
A report on the matter has been submitted to the Election Commission of India for further action, the officer added.
Congress leader Raje Gowda had won the 2023 Assembly polls from Sringeri by 201 votes, defeating his nearest rival Jeevaraj.
Addressing a press conference in Bengaluru, Siddaramaiah said the High Court had directed the recounting of postal ballots and that irregularities were noticed during the exercise conducted on May 2.
“This is a clear case of criminal conspiracy,” Siddaramaiah said, alleging that valid votes cast in favour of Raje Gowda were altered after being accepted by counting agents of all parties, including Congress, BJP, and JD(S).
He claimed that during the recounting of postal ballots, 255 votes were initially accepted as valid by all agents but were later tampered with by subordinate officials.
“There is a second mark on the votes polled in favour of Raje Gowda. They had accepted these as valid votes. Subsequently, another mark was made by officials. This is a clear case of criminal conspiracy,” he said.
When asked who was behind the alleged conspiracy, the CM replied, “It was hatched by Jeevaraj and others. It is planned.”
Siddaramaiah further alleged that the returning officer acted improperly by declaring the result despite the presence of an Election Commission observer during the recounting.
“Immediately after the counting, the returning officer announced the result. He should not have done so; this is against the law,” he said.
He pointed out that Raje Gowda had originally won by 201 votes, but after the recounting, the BJP candidate was declared the winner by 52 votes.
“The BJP has committed a criminal act of conspiracy. This is not vote chori but vote dacoity,” he alleged.
The CM said a police complaint had already been filed by Raje Gowda’s election agent, Sudhir Kumar, and emphasised the need for electoral integrity.
“We want transparency and free and fair elections. That is what our Constitution mandates,” he added.
Stating that the government would pursue legal remedies, Siddaramaiah said, “We are preparing an appeal challenging the returning officer’s announcement in a court of law.”
Responding to a separate query on elections in other states, the CM said there appeared to be an anti-incumbency factor in West Bengal, while results in Tamil Nadu were “surprising,” adding that Vijay’s party was emerging as the largest there.
Following the victory of party candidates in Bagalkote and Davanagere South, Siddaramaiah expressed confidence about future electoral prospects in Karnataka.
“Even in 2028, we will win the Assembly elections. We will come back,” the CM said.
Siddaramaiah added that he would order a forensic examination into the alleged tampering of postal ballots.
