With an aim to further strengthen the drug safety norms, the state drug controllers have been asked by Central Drug Standard Control Organization (CDSCO) to act tough against pharma firms which fail to meet the drug stability tests for the products in the market.
It has now come to the notice of the CDSCO authorities that some of the medicines sold in pharmacies were found to be inefficacious and did not last their potency till their expiry date as mentioned on the package. The state drug controllers have been asked to act tough and impose stringent regulations against firms violating the drug safety norms and ensure that the stability tests are indeed conducted for every batch, before launching their product in the market.
According to state drug control officials at Telangana State Drug Control Administration (TDCA), this specific directive from CDSCO to carry out stringent stability tests comes in the backdrop of growing complaints from the public and medical practitioners that some of the basic prescribed drugs like paracetamol, cough syrups, capsules and even some of the high end drugs for cancer have failed to meet the intended expectations in curing the diseases.
“With complaints flooding from medical doctors and public alike, the CDSCO has conducted the stability tests on some of the basic medicines and found that their efficacy and potency did not last up to the expiry period mentioned on the packaging strips. That means a few drugs in the market did not have the required stability. In view of this, the state controllers were ordered by CDSCO to carry out checks on every batch of production and ensure quality and safety of the medicines in the market,” informed a Senior Drug Controller Officer from TSDCA.
Explaining further on the duplicity about the potency of some of the medicines available in the market, Dr. Sanjay Reddy, President of Telangana Pharmacy Association said, “There have been lot of instances witnessed where paracetamol 650 mg was administered, but it was found to be ineffective as only 350 mg of the ingredients was active. The same 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.”
Pharmacy experts revealed that 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 and other cheaper sources is also one of the major reasons for not withstanding the intended stability tests.
Senior drug control officials observed that some companies which are exporting the medicines to highly regulated foreign countries are following all the regulatory norms relating to stability of the drugs, however when it comes to supplying the same medicines to domestic markets and lower income economies these companies are resorting to cost cutting and using poor quality active pharmaceutical ingredients.