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Pharma industry opposes 'red line' plan on antibiotics

'Changes suggested by govt to curb abuse are confusing'
Last Updated 23 October 2016, 19:43 IST

The Centre’s plan to curb abuse of antibiotics and psychotopic medicines has faced opposition from a section of the pharmaceutical industry that felt the changes suggested by the government will confuse the patients and sellers.

The Union health ministry in August came out with a draft notification asking the industry to print a red vertical line on the packs of 13 types of prescription medicines, including antibiotics. The vertical line, 5 mm in width, will also carry the words “Scheduled Drugs”.


The purpose is to inform the chemists not to sell or buy these drugs without a prescription. The notification has been opposed by the Indian Drug Manufacturers Association, which said the red line would mislead the consumers besides increasing the medicine cost.

Besides the antimicrobials, 12 other types of medicines are to carry the red line on their packs. They are narcotics, analgesics, hypnotics, sedatives, tranquillisers, corticosteroids, hormones, hypoglycemic, antiepileptics, antidepressants, anticoagulants and anticancer drugs.

Other drugs mentioned in the Schedule G, H, H1 and X of the Drugs and Cosmetics Act, 1940—medicines that should be sold only with a doctor’s prescription— will have to carry the red line.

“As the red line proposed is not less than 5 mm in width, almost all blisters, strips, packs, foils, vials etc will have less space for printing the legal text matter. Hence there will be need to increase the dimension of the blister strips and packs for the same content of tablets and capsule, which will increase the packing material and labeling cost,” IDMA wrote to the ministry.

The notification comes in the wake of an order from the Drugs Controller General of India (DCGI), which asked the pharmaceutical companies to print the red line on the packs of antibiotics.

The draft notification not only expands the scope of the DCGI order by bringing in more types of medicines under its purview, but would also seek to subsume the executive order once the final notification is gazetted. Moreover, to decrease the abuse of narcotic and psychotropic medicines, the notification made it mandatory for the pharmaceutical companies to print Nrx on the pack. This proposal, too, has been opposed by the IDMA.

The industry body claimed printing the Nrx would be misleading for the stockists, distributors and chemists. Also a common symbol should not be used for narcotic and psychotropic drugs, and controlled substances.

Adding more information on the label, the IDMA argued, would lead to confusion rather than clarity.

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(Published 23 October 2016, 19:43 IST)

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