Even though amendments have been made on Drugs and Cosmetics (D&C) Act to enable the common man to access quality drugs and the Food Safety and Standards Act (FSSA), 2006 has been implemented for good quality foods to the citizens in the country, both the Acts are often unable to regulate the prices of drugs and food items because of the unethical practices indulged in by manufacturing companies, commented M Rajendran, market analyst and former director of drugs control department, Tamil Nadu.
So, this is time for the new government to contemplate on a new policy to regulate all kinds of drugs without leaving any loopholes to the manufacturers for evading the Drug Price Control Oorder (DPCO) 2013, and to explicate how neutraceuticals/food supplements could be controlled under FSSA. Though the word neutraceuticals is defined in the FSSA, no further rules, regulations or control has been prescribed, he said.
According to him, several companies are converting drugs into the form of dietary supplements and changing or adding one or more ingredients into a price controlled drugs to come out of the price control order. Amino acids, vitamins, beta carotenes, minerals etc are purely drugs, but these preparations are marketed as dietary supplements. In the name of food supplements, drug companies are escaping from the clutches of DPCO. The new government should immediately find some ways to put an end to this kind of unethical business of the manufacturers as it will affect the lives of the poor people, said the drug expert while speaking to Pharmabiz.
“How can a capsule or tablet be considered as food item in the name of dietary supplements/ food supplements? When there are good quality drugs under the control of D&C Act available in the market for all diseases including those emerging from lifestyles, where is the necessity to include neutraceuticals in FSSA? It will pave way for exploitation. When there is DPCO to have a check over the exorbitant rates fixed by the manufacturer, there is no price control over food/neutraceuticals/manufactured food,” he said.
New drug licence is issued by DCGI based on some technical parameters. Since there is provision in the DPCO that new drug should not be controlled and protection is there for 20 years under patent act and five years under DPCO, the businessman obtains licence in the form of new drugs and escapes from the clutches of DPCO. He changes or adds ingredients to be eligible for exemption from price regulation, and thereby exploit the innocent poor people in the country. So, Union health ministry should consider amending such clauses in the DPCO in order to save the public.
Further, he said this is time for the government to form an apex body incorporating members from FSSA, D&C Act, Competition Commission of India Act, Consumer Protection Act and Patent Act to formulate strategies to stop jumping out of price control by manufacturers.
As examples, Rajendran said though government has fixed Rs.25 for ciprofloxacin tablets 500 mg, certain companies are selling it for Rs.95 and coming out of the purview of DPCO. Beta carotenes with vitamin combinations (capsules) is sold at Rs.320 in place of Rs.20. paracetamol injection 100 ml is charged Rs.300. But normal saline and dextrose injection 540 ml are priced at Rs.28. He said overpricing is done more on combination products.