The traditional medical researchers and market analysts associated with an Indian Medicine Research Centre in Chennai has found in their study that the drug inspectors in the department of ISM in Tamil Nadu are not recommending for any penal action against manufacturers whose drugs samples are proven non-compliant to quality standards.
The drug testing laboratory at Anna Nagar often finds non-compliance of standards in the tests conducted by it on samples brought by the drug inspectors. But the manufacturing companies, somehow, escape from all kinds of punitive actions.
In Tamil Nadu, the district ISM medical officers are acting as the drug inspectors who often inspect the pharmacies and drugs stores in the government hospitals and take samples for testing. Notices are issued to the companies whose products are found non-compliant. But, no prosecution is registered against any company, alleged Dr T Thirunarayanan, the special invitee of the Central Council of Indian Medicine and the secretary of the Chennai based Centre for Traditional Medicines and Research (CTMR).
When asked about the multi-state cooperative society for Indian medicines, IMPCOPS, he said it has also been served notices for non-compliance several times, but there is no report of any action taken by any drug inspector so far.
According to him the Siddha medical officers who are assigned to do regulatory jobs lack proper training in the area. So, the enforcement of Drugs & Cosmetics Act in the area of Indian medicines is not effectively carried out in Tamil Nadu. Besides, several of the posts of drug inspectors are lying vacant for years. Although the state government is willing to initiate measures to streamline the field and promote Indian medicines, the major hiccup in the way is the senior level officials in the department. There are myriad cases of litigations on promotions and postings by the officials that interrupt the government efforts.
However, on the apathy of the government in issuing licences for new products, Dr Thirunarayanan said the department of ISM is insisting on clinical trial reports. But the manufacturers of proprietary drugs are not able to provide the reports for want of approved clinical research centres and pre-clinical lab facilities. In addition to this, there is no set of proper guidelines issued by the department of Ayush regarding clinical trials.
According to sources from CTMR, the Centre is ready to provide training on regulatory procedures to the drug inspectors who are recruited from academic side and administrative field. They may not be aware of the enforcement rules and processes. A proposal of this kind is getting ready with CTMR to be forwarded to the central Ayush department and to the Union health ministry for consideration.