Following the State Government’s decision to attach the Drug Testing Laboratory (DTL) with the Government Central Pharmacy (GCP), the ISM drug samples taken by the regulatory officials in Karnataka are no longer being tested at any recognized government laboratory in the country.

Sources told Pharmabiz that the State Government is not allowing the State Directorate of Indian System of Medicine and Homeopathy (ISM&H) to test drug samples at its full-fledged drug test lab (DTL) for the past 18 months. This situation arose since the State Government attached the operations of the DTL with the GCP, which is a production unit for drugs for hospital supplies in the state. As per the norms, the DTL can only test the drugs manufactured at the GCP.

This lacuna in rules forced the department to send its drug samples to the Central Government authorized ISM laboratory at Ghaziabad for testing. However, this lab has been refusing to test the samples, as that laboratory is focused only into basic research related to ISM medicines. The resultant stalemate forced the State ISM department to approach the drug testing lab of the Karnataka drugs control department, which is only geared up to test allopathic formulations. Although the drugs control department obliged for a while, now this lab is not testing the Ayurvedic drug samples, it is learnt.

Sources said the two drug inspectors at ISM&H are now only in-charge of granting manufacturing licenses and the department is not able to check Ayurvedic drugs for its quality.

Sources said the DTL was modernized by spending Rs One crore, allotted by the Central Government. The modern equipments are now gathering dust instead of using it to test ISM drug samples collected by the inspectors to check for its quality, informed the officials.

At present, most of the leading ISM drug companies which lack dedicated drug testing facilities test their products at MS Ramaiah, Foundation of Revitalisation of Local Health Traditions (FRLHT) and Bangalore Test House to verify the quality of their products. The directorate cannot utilize private sector drug testing facilities since it is mandatory to check the samples at a government set-up laboratory, said officials.

In addition to the problems of testing drugs, the directorate also lacks adequate drug inspectors. Though the government has created the post of an Assistant Drugs Controller to mainly ensure co-ordination between the inspectors and the director of ISM & H, the post is lying vacant for the last three months.

Department sources said the State ISM &H received a budget allocation of Rs 30 crore for the period 2005-06, including Central assistance to the tune of around Rs 8.5 crore. While the Central assistance is to strengthen infrastructure at the directorate, the state funds are for administration purposes, said sources.