The All India Organization of Chemists and Druggists (AIOCD) and its state affiliate units will soon approach the union health ministry to demand deferment of the implementation of Schedule H1 as it is being misused by quacks in remote parts of the country as there are drawbacks and ambiguities in the Schedule in its present form.

A letter to this effect has already been sent to the Members of Parliament (MPs) recently. According to the trade body, Schedule H1 in its current form is draconian and amounts to a non-bailable offence if not complied with.

Most of the chemists across the country have not been able to follow the newly amended Schedule H1 which has come into effect in the country from March 1, 2014 due to lack of awareness, cumbersome record keeping, lenient regulatory enforcement and the cost to set up a robust electronic system.  

Offenders for non-compliance of Schedule H1 may face penalty ranging from FIRs and cancellation of licenses based on the merit of the case. The central government in September 2013 had amended the Drugs and Cosmetics (D&C) Rules to insert Schedule H1 to curb the indiscriminate use of antibiotics and some other vital drugs, by placing 46 antibiotics under this special category.

AIOCD claims to represent over 7 lakh chemists from across the country. The trade body also reasons out that most of the states except Maharashtra have not been able to implement it as it has taken almost three months for the state drug controllers to sensitise the chemists towards its implementation since it was introduced on March 1, 2014.  Moreover, physicians from other systems of medicine have been practicing it in most of the states despite their ineligibility which is detrimental to patient safety.

Only a registered medical practitioner from allopathy is eligible to prescribe Schedule H1 drugs. Among other issues, it has also been argued by AIOCD that implementation of Schedule H1 has become a very expensive proposition for the patient in emergency situations when the pharmacist denies Schedule H1 drug to the patient and asks for a fresh prescription from a physician. The patient has to go the extra mile to get the drug prescribed again at a hefty consultancy fees from the physician ranging from Rs.200 to Rs.1000.  

Clarity has also been sought on whether computerised bill is an authorised version or the chemist has to adhere to the manual billing system for compliance to Schedule H1. "The purpose of Schedule H1 has not been understood by the public and that only pharmacists have the onus of maintaining the register is ironical. Besides this, due to the shortage of MBBS doctors in many parts of the country, medical store owners will have the leniency to produce fake bills by putting names of doctors on the bill and rake in profits at the cost of patient safety," said a pharmacist.