Drug authorities in Kerala, Karnataka and Tamil Nadu have found six commonly used drugs as substandard in the random quality testing conducted in the drug testing labs in these states. All the three states have issued 'note of caution' to pharmacy outlets, hospitals, nursing homes and private practitioners.
In a random selection of drugs from the pharmacy outlets in the three states it was found that all the three labs have unanimously opined that drugs are not known to contain the requires bulk drug in adequate quantities. Of these substandard drugs, three are pain killers, one is an animal health drug and two injections.
The drugs that have been found substandard are: Ibru Plus (ibuprofen, paracetamol and magnesium oxide) tablets manufactured at GS Pharmaceuticals, Haridwar, Combisun (ibuprofen, paracetamol and magnesium oxide) produced at Haridwar by Sun Life Sciences, Powertex -250 injection produced by MMG Health Care in Himachal Pradesh, another pain killer Aspirin which is a delayed release tablet USP: Loprin DS manufactured by Kalinda Medicare Pvt Ltd in Uttarakhand, Sulphaquinoxaline solution for veterinary use manufactured by Sterling Lab at Sipcot Industrial Area at Hosur in Tamil Nadu and Thiopentone Sodium injection manufactured by Vital Healthcare located at Nashik.
According to Karnataka drugs controller Dr BR Jagashetty, the not-of-standard quality drugs are also a serious issue. Our drug inspectors are on their rounds and pick up drugs off the counter at random. All these not of standard quality drugs have come in from outside the state of Karnataka.
The excise free zones have known to be a hub for not of standard quality. Many of the manufacturers do not adhere to quality production practices, according a section of pharmacists.
"Not of standard quality drugs is a bane to the pharma industry. There is need to implement the withdrawal of supplies and stop production orders of these drugs on a war footing. Since most of the companies are located outside the state, it is difficult to monitor the recall process. Since many of the active ingredients indicated in the substandard drugs are common contents used by many companies, we need to know the exact quantity of the bulk drug or intermediate which was found missing in the formulation. The drugs control authority needs to provide clear details on the reasons for declaring the drugs as not-of-standard quality," said Jatish N Seth, secretary, Karnataka Drugs & Pharmaceutical Manufacturers Association (KDPMA) and director Srushti Pharmaceuticals.
The issue of substandard drugs is only seen in the press as regular announcements which is a mandatory requirement. But the implementation of recall is not fool-proof and there is no monitoring by the regulatory authorities.
Even if there is official communication by the company much of the recall does not take place in real sense. This can happen only if the drug regulatory enforces a higher penalty fee which will keep these manufacturers on their toes to adhere to quality production and constant checks at each phase of production. There is also need for surprise inspections to see if drugs are recalled. Regulators also need to provide their support to help the company to withdraw the product to prevent dishonest practices, said Kaushik Desai, CEO of Global Pharmatech.