Even as the state of Kerala consumes about 10 per cent of the medicines marketed in the country per year, the quality control system of the drugs control department continues to be weak and incompetent. Hence, a public-private-partnership (PPP) scheme may be developed to improve the quality control testing of drugs, according to Dr C S Satheesh Kumar, former drugs controller of Kerala and vice-president, operations, of the Kochi based Agappe Diagnostics.
In a telephonic interview with Pharmabiz, the former DC said a major quantity of the drugs supplied to the government hospitals are found at higher rate of substandard quality. Even ten percent of the total supply cannot be tested at state laboratories.
He said Kerala government is getting around Rs. 300 crore per annum towards sales tax from the drugs market; but the drugs control department remains as a service department with poor financial assistance from the government. The law enforcement authority is unable to assure the quality of drugs marketed in the state from other states. Less than one percent of the drugs sold in Kerala are manufactured by local companies.
“Very few number of drugs marketed and distributed in various places in Kerala is taken for analysis. Out of the 2,50,000 odd batches of drugs moving in the market per annum, less than 2 percent is taken for analysis. This should be above 10 per cent for satisfactory sampling. For this, new mechanism has to be developed by joint partnership of private and public agencies”, he suggested.
According to him, measures should be made to ensure hundred percent sampling, and it should be made compulsory for government procurement. For better quality criteria, modification is required in the tender process and the lowest rate (L1) quotation system has to be avoided. Government should procure a lion portion of the requirement from the local manufacturers and price preferences and other incentives should be given to them.
Regarding efficiency of the drugs testing lab (DTL) under the department, Dr Satheesh added that the government laboratory at Thiruvananthapruam is not functioning in full capacity. The second regional drugs testing lab established at Ernakulam has not started functioning fully due to non-cooperation of senior officials in the department. He alleged that the rude and distorted attitudes of lab authorities spoil the whole system of the quality control, leaving all options of quality assurance.
As a suggestion to improve the quality control system, he said if the lab facilities at the pharmacy colleges can be utilized for sample analysis, majority of the drugs distributed in the state can be tested. There are 25 pharmacy colleges working in Kerala. All these colleges altogether can contribute a minimum rate of 15000-18000 samples per year provided one college is able to do analysis of 50-70 samples per month in survey sample analysis.