Micro Labs, the largest pharma company of Karnataka and Healthline of Vetcare, a leading veterinary company in India are accused of manufacturing drugs which are not of standard quality following a test report released by the Drugs Control department here in the State.
In a communiqué here from the drugs control department, acting drugs controller H Jayaram said that the two products namely, Nutriliv injection of Healthline and generic tablets of Vitamin B Complex with Vitamin C and Folic acid from Micro Labs are found to be not of standard quality after a government analyst from the drugs testing lab submitted a report on the two products.
Jayaram told Pharmabiz.com that now the manufacturers will have to challenge the test report before the Court and only after the analysis of the samples by Central Drugs Lab, Kolkatta the two companies will be able to market the products.
He said that the two products may have been manufactured in the best of production facilities and could have been of top standard going by the number of stringent checks these companies conduct. "But the fact remains that all drugs are sensitive to sunlight and moisture. One could blame the method of storage of the drugs after it left the premises of the companies to the market or stores of the healthcare establishments and clinics which purchased the drugs."
The acting drugs controller further stated that the drugs, consist of multi ingredients, have undergone crucial sensitive tests. "However, there could be a possibility for the extraction process to be faulty or the instrument used for testing to be defective or even the analyst who is given the responsibility could have erred in the examination of the drugs," he informed.
Sources from Micro Labs did not comment on this matter. But the analyst from the Karnataka drugs control lab is understood to have admitted that it was a human error, which was regretted. There is enough proof with the company that the product was tested and was giving positive results. But these details were not be shared with the media.
Micro Labs manufactured the product at one of its three state of the art manufacturing facilities meeting the requirements of UK MCA and US-FDA standards located at the SIPCOT in Hosur.
Healthline Pvt. Ltd is the only company manufacturing both large volume and small volume parenterals in Karnataka. They are the first company to come out with intravenous fluids in pouch packing in southern India. The company has the state of art manufacturing facility to aseptically fill and seal IV fluids in nontoxic PVC pouches. The veterinary parenterals are specially manufactured on contract basis to Vetcare, one of the biggest veterinary pharmaceutical companies in India.
Meanwhile sources from the industry are vehement about the 'not of standard quality' drugs accusations charged by the drugs control department. On condition of anonymity they stated that the drugs department should not have rushed to the 'press' in haste before clarifying the same with the Micro Labs and Healthline.
Commenting on the not of standard quality product list released by the drugs control department, R S Iyer, Pharma analyst and former head of quality control for companies like the erstwhile Parke Davis, Glaxo Pharmaceuticals said that analysis of the product quality was a critical phase before marketing approvals are sought. Even if the companies maintained the highest production quality standards, the standard of drug analysis conducted at the dedicated drugs testing labs in the country can be questioned. It is unfortunate that credibility of the drugs department and the companies are becoming an issue. Iyer further pointed out that in the West too there are instances of drugs scams, which run into billions of dollars, but there are no apprehensions on quality of the drugs for the consumers like what is happening in India.