Chemists and pharmacists have threatened to launch a nationwide agitation against a government order making it mandatory for them to maintain a separate sale register for sleeping pills, antibiotics and anti-tuberculosis drugs. They will sit in dharna in the capital on March 24. The March 1 order comes even as the Health Ministry has allowed chemists to sell antibiotics listed under Schedule H1, but manufactured before February 28, without the new labelling requirements.
However, they have been asked to follow other instructions for sale of these antibiotics with regard to prescription and maintenance of sale records as per the amended rule under Schedule H1, according to official sources.
The pharmacists claimed it was “impractical” to maintain the register and implement the order in all 6,00,000 retail shops all over the country.
As per the order, retail shop owners have to maintain a new register while selling several hundred drugs containing one of the 46 molecules identified by the government. These drugs were categorised under the new schedule, H1. The register will have the names and addresses of doctors, names of patients and of the drugs and quantities supplied.
“This is impractical because of patient pressure at the shops. We receive 300-400 prescriptions every day and maintaining a manual register would be cumbersome and time-consuming,” said Kailash Gupta, president, All India Chemists and Distributors Federation. The pharmacists say maintaining a register will mean duplication as a large number of shops in big cities use software for billing prescription drugs, and the order would be a new tool for harassment at the hands of drug inspectors.
As for the relaxation of labelling requirements, it came following representations by the trade bodies, which citied difficulties in re-labelling products manufactured earlier. The government had amended the Drugs and Cosmetics Rules to insert Schedule H1 category for regulating use of antibiotics. But it placed only 46 antibiotics under the category instead of the original proposal to include 91 drugs.
The government also made it mandatory for these listed antibiotics carrying a warning. If it contains a drug substance specified in Schedule H1, the formulation shall be labelled with the symbol Rx in red, conspicuously displayed at the left top corner of the label, says the government notification.