Owing to inadequate infrastructure, the Kerala State Drugs Control Department is groping in the dark to ensure quality of drugs. Adding fuel to the fire, nutraceuticals (food or food products that reportedly provide health and medical benefits, including the prevention and treatment of disease) are going to make a grand entry into the market.
Although beneficial for the pharmaceutical companies, the Drugs Control Department cannot ensure the quality of nutraceuticals since there are no clearly defined rules in this regard.
“In India the prices of 74 drugs and its combinations are determined by the National Pharmaceutical Pricing Authority (NPPA). The pharmaceutical companies do not have any role in deciding the prices. But to overcome this ‘hurdle’, companies have started selling drugs in the name of dietary supplements for which only a licence under the Prevention of Food Adulteration Act is required. When the nutraceuticals are introduced, companies can sell drugs without any control on price and quality. The drugs control department cannot take up these cases,” cautions M R Pradeep, assistant drugs controller, Ernakulam.
There are 60 pending cases related to the sale of dietary supplements of 40 companies in the Kerala High Court. As many as 10 cases are pending this year alone. When nutraceuticals enter the market in a big way, the department fears that there may be a spurt in the number of cases.
“If drugs are sold in the name of nutraceuticals, the companies can determine the price. The sales of these products will be purely based on the incentive given to doctors by the companies. Since there are no quality standards, the cost of production of nutraceuticals is less compared to drugs, which require Good Manufacturing Practice (GMP) certificate. Nutraceuticals can be sold anywhere without a proper medical prescription,” Pradeep added.
The continuous usage of nutraceuticals can cause liver cirrhosis, kidney damage, diabetes and hypertension. The Indian Drug Manufacturers Association (IDMA) is pressing the government to give a green signal to these products. It is expected that the central government will comply with the demand by the end of this year.