The complaint filed with Kerala drugs control department against the Chennai-based Pothigai Pharma alleging adulteration and admixture of ‘sildenafil citrate’ in their ayurvedic capsule, Sulthan Forte, establishes one fact that the inspection mechanism under the department of Indian System of Medicines (ISM) in Tamil Nadu is feeble and inadequate.

Neither the department of health and family welfare nor the department of Indian System of Medicines is taking any positive and reliable step towards strengthening the enforcement of chapter 4 (a) of the Drugs and Cosmetics Act which deals with Indian medicines, sources alleged.

Last year, a comprehensive study conducted by the Chennai-based traditional medical research group, CTMR, found that very few inspections were carried out at the ISM retail stores and at the premises of wholesalers and manufacturing companies by the district siddha medical officers (DSMOs) who are entitled to do inspections. The study also confirmed one fact that the DSMOs were not recommending any penal action against manufacturers whose drugs samples were proven non-compliant to quality standards.

According to experts and regulatory officials in the field, the ISM department has no separate drug inspectors for enforcing drug acts as in the case of allopathic wing. It is the duty of the drug inspectors to inspect a premise and collect samples. Unfortunately the government has not created posts of ISM drug inspectors and the department heads never recommended for creation of such posts. All the hurdles and inadequacies for the growth of the department and for strict enforcement, can be avoided and solved once the government appoints a capable and sincere officer as the head of the department, comment industry sources.

A retired drugs controller while speaking to Pharmabiz, said most of the commissioners appointed by the government to look after the ISM wing do not know anything about Indian medicines and the Drugs and Cosmetics Act. Even the siddha medical officers are also unaware of the drugs laws and enforcement jobs.

According to him, there are two options for the government to develop the ISM system and the department. One is to depute some drug inspectors from the allopathic drugs control directorate under the supervision of an ADC for the exclusive inspection jobs of ISM medicines, especially siddha in Tamil Nadu. The second option is, since the Commissioner of Indian Medicines is not taking any supportive step for improvement and enforcement, the department should be brought under the Commissioner of Tamil Nadu Food Safety and Drugs Administration (FDA). Until 2005, the department of Indian System of Medicines was functioning under the directorate of drugs control. The state government has to take the interest for this integration.

Dr. T. Thirunarayanan, member of the Advisory Board under the ministry of Ayush, government of India, said as long as the lukewarm attitude of the officers at the department of Indian System of Medicines continues, especially of the Commissioner, the department will not improve in Tamil Nadu. Or else, the health minister himself should interfere in the administration of the department.