To effectively prevent the sale of counterfeit, falsified, and substandard medicines, and to ensure that quality drugs are accessible to the population at a fair price, the Department for Food and Drug Control of UP has issued important guidelines regarding institutional drug supply with special discounts.
The Department emphasized the need for transparency in invoicing and the actual delivery of medicines at the level of companies, C&F agents, superaggregators, and stockists.
It was found that various drug manufacturers and distributors provide special discounts to their C&F agents, superaggregators, or stockists for the needs of doctors, hospitals, and nursing homes.
In some cases, companies or C&F agents issue invoices not in the name of the doctor or institution intended to receive the medicines, but in the name of their stockist. Subsequently, the stockist supplies the medicines not to the doctor, hospital, or nursing home indicated on the invoice, but to another pharmacist or firm.
According to the directive issued by the Commissioner of the Department for Food and Drug Control, Roshan Jaikb, the increase in sales by stockists occurs because they can sell medicines obtained with a special discount at a lower price compared to other wholesale sellers.
This negatively affects the principle of healthy competition in the market. The situation becomes even more serious when fake invoices are prepared under the guise of special or cheap medicines for the sale of falsified and counterfeit drugs.
The Department noted that such actions were identified during the campaign against fake and substandard medicines, labeling them as illegal trade and extremely dangerous to public health.
Under the new instructions, the company, C&F agent, superaggregator, and stockist must guarantee that the invoice is issued specifically in the name of the doctor or institution to whom the drug delivery is actually intended.
It is also necessary to eliminate abuses of the system of indicating different entities in the invoice as 'Bill To' and 'Shipped To'. That is, if the invoice is drawn up in the name of a specific doctor or institution, the delivery must be made to that specified location.
To prevent redirection and improper use of medicines supplied with a special discount, it has become mandatory for the labels and packaging to clearly state 'INSTITUTIONAL SUPPLY' either by the manufacturer or the C&F company. This measure will simplify the identification of the drug as intended for institutional supply, preventing its illegal diversion to the regular market.
In accordance with the provisions of the Drug Rules, instructions regarding the supply of medicines sold after consultation with a doctor—medicines from lists H, H1, and X—have been clarified. The supply of such medicines must only be based on a written and signed purchase order from a registered doctor, hospital, polyclinic, or nursing home. Furthermore, retaining a copy of the corresponding purchase order for at least two years is mandatory.
The Department stressed that if unauthorized supply of medicines is discovered by any company, a case will be initiated in accordance with the Law on Drugs and Cosmetics of 1940 and relevant regulations.
The Department stated that medicine is an essential necessity, and according to the Law on Essential Necessities of 1956, considered together with the Decree on Price Control of Medicines (DPCO), 2013, the availability of medicines for the population must be maintained. This is precisely why the system for controlling the transparency of sales of medicines with special discounts, proper identification of supplies, and prevention of unauthorized redirection was created.
The Department instructed all relevant companies, C&F agents, superaggregators, stockists, and pharmacists to ensure strict compliance with these directives.