The All India Organisation of Chemists and Druggists (AIOCD) has expressed reservations over several provisions related to pharmaceutical trade in the draft pharmaceutical policy released by the Department of Pharmaceuticals (DoP) recently.

Issues such as capping trade margins, implementation of e-Pharmacy and e-Prescription and bar code containing price information on drugs in the draft policy have evoked sharp criticism from the trade body.

The Drugs and Cosmetics Act has not mentioned e-pharmacy and e-prescription. The government first needs to introduce amendment to the Act to pave way for implementation of e-pharmacy and e-prescription. The stakeholders like trade body should be taken into confidence before making any amendment to the Act in this regard. We have time and again opposed the implementation of e-pharmacy unless the requisite infrastructure facility is put in place, said Suresh Gupta, general secretary of AIOCD.

He said “The Act was drafted at a time when e-retail was in practice. An ecosystem needs to be created to encourage tech based distribution systems. A robust tracing and tracking system should be put in place to monitor drugs which are sold online without a prescription and in what quantity.”

The draft also focused on promoting generic drugs. To aid and assist the registered medical practitioners in prescribing medicines in the generic names, e-prescription will be put into operation whereby the prescriptions will be computerised and the medicine name will be picked up from a drop down menu of salt names.

The e-prescription provision has not gone down well with the AIOCD. A significant number of retailers in rural areas are not equipped with adequate IT infrastructure. They do not have consistent access to the internet. How can e-prescription work there? he asked.

The trade body also criticized the draft policy's focus on regulating trade margins to make drugs more affordable for people.

“For this, the government should lower the prices of medicines rather than curtailing trade margins. This will pose a threat to survival of traders. We have appealed to the government to provide wholesalers a margin of 10 per cent margin and retailers a margin of 20 per cent. The AIOCD had sent a proposal to NPPA long time back seeking a margin of 35 per cent for retailers on generic drugs and 15 per cent margin for wholesalers,” he added. In generics, there are a margin of more than 100 per cent.

According to the draft,“The issue of unreasonable trade margins and bonus offers by various stockists, distributors and retailers has been adversely affecting both the industry as well as consumer interest. After detailed stakeholder consultations, the level of trade margins will be prescribed to create a level playing field for the industry and to bring down the prices.” It also states that institutions that procure directly from manufacturers will also be subject to this regulation.

Appreciating the policy's recommendation on “one company–one drug–one brand name–one price to cripple pharmaceutical companies' marketing strategies to manufacture the same drug at different prices and brand names, Gupta said due to lacunae in policy, varied categories of drugs like ethical, generic, branded generic containing the same molecule are priced differently by the companies. We have long demanded that NPPA should look into the different prices of drugs made of the similar molecule, he said.

In the pharmaceutical industry, about 2,500 pharmacopoeial salts are manufactured but there are more than 60,000 brand names with varying prices.  

The draft policy's emphasis on compulsory provision of static bar code containing price information on drugs has received sharp response from the AIOCD. The draft says bar code reading and computerized billing will be introduced in pharmaceutical distribution and retailing.

We have extended support to barcoding on products in domestic market. It will help the government create authentic database on pharmaceutical sector containing details on manufacturer wise, brand wise products and product wise, brand wise manufacturers and will do away need for e-portal. We are against barcoding containing price information on drugs, he concluded.

The draft policy also laid down several other policy prescriptions that include enhancing quality standards, faster approvals, giving a boost to indigenous manufacturing and encouraging research and development, reducing dependence on China for raw materials.