These tests are make-or-break for a drug

NEW DELHI: Four of the six drugs supplied to Delhi government hospitals whose samples were found to be 'not of standard quality' failed the dissolvability test, affecting the efficacy of the medicine. Others failed the assay test, or ingredient and composition measure, and yet others showed 'related substances' that affected the purity of the drug.

The test reports accessed by TOI revealed that sodium valproate, Levetiracetam, Amlodipine and Cephalexin fell short on the dissolvability parameter.Experts said some of these are critical life-saving drugs. While Cephalexin is an antibiotic used for treatment of lungs and urinary tract infections, Dexamethasone is a steroid for curing life threatening inflammation of the lungs, joints and other body parts. Levetiracetam and sodium valproate are anti-epilepsy and anti-anxiety psychiatric drugs and Amlodipine is used to control blood pressure.
According to experts, the dissolution test measures the extent and rate of release of a drug in its dosage form of tablets and capsules. The dissolution of a drug is an important factor for its bioavailability and therapeutic effectiveness. Additional professor HN Yadav of the pharmacology department at AIIMS said that sodium valproate, Levetiracetam, Amlodipine and Cephalexin failed the dissolvability test as per the standard of Indian Pharmacopoeia (IP) 2022. He explained poor dissolvability affected the rate of absorption by the body, thus hampering the drug's efficacy. If a patient consumed such a drug for epilepsy, the individual could well suffer episodes of seizures even after taking the medicine, he said.
The IP standard for the rate of absorption of the sodium valproate tablet tested is 75%, which Dr Yadav explained as meaning that if someone took a 100mg dose, then 75mg should be accessible for absorption. But when the medicine did not comply with the required IP standard, the patient would be in trouble. "Despite taking the drug, it is possible that the patient would not get relief," he said, adding that drugs that don't comply with I should not be sold and any non-conforming batches should be immediately withdrawn from the market.
As for the problem of 'related substance', Amlodipine tablet is allowed maximum impurity as per IP standard of 0.5%. The tested tablet had 6.5 %. Long-term use of such a drug would prove harmful for health, Yadav said. As for the deficiency in the 'assay' or quantity measure, Dexamethasone tablet was shown to have quantity less than the IP standard.
Earlier this week, Delhi government's directorate of vigilance sent a report to lieutenant governor VK Saxena saying it had received complaints from patients about "sub-standard" medicines being supplied in the state-run hospitals and clinics, which did not have the "desired efficacy". On July 25, three teams of drug controllers and inspectors picked random samples from the state-run Lok Nayak Hospital, Deen Dayal Upadhyay Hospital and the Institute of Human Behaviour and Allied Sciences that cater to thousands of patients every day and sent them for testing at two government and three private laboratories.
The report stated that of 43 samples that were sent to the government labs, three failed the tests and 12 reports were pending. Of the samples sent to private labs, six failed the test.
"Drugs such as Amlodipine, Levetiracetam and Pantoprazole failed in both the government as well as private labs. Three drugs, Cephalexin, Dexamethasone and sodium valproate, whose test results were received on Wednesday, failed in the private labs," said a government official.
While the vigilance directorate has sent the case to CBI for investigation, the state government has ordered the immediate withdrawal of all medicines not meeting standards from the market.
Parl breach: Police seek nod for polygraph test of accused | page 22
New Delhi: The special cell of Delhi Police on Thursday moved the court of additional sessions judge Hardeep Kaur, seeking permission to conduct the polygraph test on all six people arrested in connection with the Parliament security breach.
Since the counsels assigned to some of the accused were not present, the court posted the matter for hearing on January 2, 2024. It was necessary for the accused to talk to their lawyers before permission could be granted for the polygraph test, the judge said.
All the six accused arrested in the case - Manoranjan D, Sagar Sharma, Amol Dhanraj Shinde, Neelam Azad, Lalit Jha and Mahesh Kumawat - 4have been remanded in police custody till January 5.
The FIR in the case has been registered under IPC sections 153 (provocation with an intent to cause riot), 120-B (criminal conspiracy), 452 (trespass), 186 (obstructing public servant in discharge of duties), 353 (assault or criminal force to deter public servants from discharge of duty), and sections 16 (terrorist act) and 18 (conspiracy) of The Unlawful Activities (Prevention) Act, 1967.
Earlier, the prosecution had told the court that the accused wanted to create anarchy in the country so that they could compel the government to agree to their unjust and illegal demands.tnn