Fully supporting the initiative of the Drugs Controller General of India (DCGI) to form a joint committee, comprising experts from Central Drugs Standard Control Organisation (CDSCO) and Food Safety and Standards Authority of India (FSSAI), to scientifically classify neutraceutical and drug products, Joint Director (Drugs) at the Directorate of Drugs Control Administration (DDCA) in Jharkhand, Dr. Sujit Kumar wanted the central government to take stringent measures to stop the sale and marketing of drugs as food supplements.

It is high time the central government intervened in the matter and restricted such unethical practices of pharmaceutical manufacturers and marketers in the interest of the nation and its people. Restriction is needed not only for protecting the health of the people, but also for restraining the pharmaceutical companies from escaping the price control, he said.

Responding to a story appeared in Pharmabiz on February 6 this year, Dr. Kumar told Pharmabiz that the DCGI’s decision was very apt and needed support from all states because these products were sold /marketed without any quality check. “No quality check is carried out on these food supplements/neutraceuticals since the drug inspectors generally do not take samples of these products as the labels mention them as dietary supplements”, he said.

Referring a court case that he won from the High Court of Jharkhand in 2015 and finally from the Supreme Court of India in 2016, Dr. Sujit Kumar said the court had observed one food supplement with dose of vitamin in therapeutic range as drug.

According to him, companies fix the maximum retail prices (MRPs) which are five to six times higher than the prices that would have been, if the same had been manufactured and sold under drug category.  The dose of vitamins in these products falls in therapeutic range and they are used for the treatment of a disease or disorder or deficiency in human beings. Physicians prescribe these products very frequently and are sold through almost all chemist shops just like drugs. On the part of medical representatives, they promote these products like medicinal products by visiting doctors regularly. The toxic effects of these so called neutraceuticals /dietary supplements cannot be overlooked, Dr Kumar said.

Regarding the court case, he said, while he was working as the drug inspector at Giridih district in Jharkhand in the year 2005, he seized one product, A to Z Gold Soft Gelatin Capsules, from a wholesale medicine shop, which was sold as dietary supplement/ nutritional supplement/neutraceutical /food supplement on a licence granted under the Prevention of Food Adulteration Act. But the active ingredient of the product was in the therapeutic range.

He filed a case against Indchemie Health Specialities Pvt. Ltd  and Alkem Laboratories Ltd for manufacture and sale of a drug product as dietary supplement in violation of provisions of 18 (a) (vi), 18 (b) and 18 (c) under Section 27 of the Drugs and Cosmetics Act 1940, with Giridih court. Followed by, the companies filed petition with the High Court of Jharkhand at Ranchi seeking discharge from the case against them. The division bench of the court in its judgment dated 09.9.2014 declared the product as ‘drug’.

Later, the companies filed special leave petitions (SLPs) with the Supreme Court of India against the judgment of the division bench of the High Court. Supreme Court in its order dated 29.7.2016 dismissed the SLPs and disposed off all pending applications, said the joint director of the Jharkhand drugs control directorate.