Hyderabad: It was mandatory for pharmaceutical companies to carry out stability tests on all drugs before marketing them. Now, state drug controllers have been asked to ensure that these tests are indeed conducted after it was found that the drugs lacked efficacy.
The Central Drugs Standard Control Organisation took the measure when tests revealed that the potency of some drugs did not last till the expiry date.
A senior drug officer said, “When prescribed drugs are not effective, it means that they don’t have the required stability. This was found in basic prescriptions like paracetamol, cough syrups, capsules as also high-end drugs for cancer. The state controller ordered checks on these drugs after complaints came in from hospitals and other quarters. We want a stability check for every batch of drugs.”
Senior pharmacist Dr Sanjay Reddy said, “We have had instances where paracetamol 650 mg was administered, but it was found to be ineffective as only 350 mg of the ingredient was active. This is the case in many other drugs and for that reason the manufacturer must conduct stability tests for every batch before releasing it in the market.”
According to sources, such discrepancies were found in drugs manufactured in units that were not properly registered and where verification processes were not followed. Even raw material for medicines in terms of chemicals, procured from countries like China, had major issues in terms of efficacy.
A senior drug inspector said, “The companies provide high quality material to regulated markets and low quality material to developing economies to cut costs. In light of this, stability tests are being demanded on efficacy of drugs.”
Poor quality active pharmaceutical ingredient like povidone iodine, an antiseptic used for skin disinfection before and after surgery, had been a major challenge. Experts said this essential drug required monitoring as its shelf life was a concern at high temperature, time taken to transport the drug and the storage facilities.
A high quality drug translates into better treatment and patient safety.
