Schedule H, Schedule X and Schedule H1 Drugs
In January 2015, the Pharmacy Council of India has published the new Pharmacy Practice Regulations 2015 to regulate pharmacy practice in India.
Important provisions are:
- Drugs can be dispensed only by a qualified registered pharmacist.
- Registered pharmacists shall not give his registration certificate at more than one pharmacy and should not allow the owner of the pharmacy to use his registration certificate without attending the pharmacy.
- Registered pharmacist shall also comply with a dress code by wearing white coat and apron with a badge displaying the name and registration number.
- Every registered pharmacist shall dispense only those medicines as prescribed by the Registered Medical Practitioner and shall not substitute the prescription.
- Every registered pharmacist shall maintain the medical or prescription records pertaining to the patients for a period of 5 years from the date of commencement of the treatment as per regulations.
- Pharmacists should promote the rational use of drugs.
- Other guidelines regarding ethical conduct of pharmacists.
The present role of pharmacists in India is just confined to collection of prescription and dispensation the drugs. In Western countries, the role of the pharmacists is patient-centric. The broader role of pharmacists and better wages in Western countries played a major role in attracting talented pharmacists away from India. Though there are more than six lakh drug stores in India but there is no culture of community pharmacy. Under community pharmacy, pharmacists are given with wider responsibility.
The newly formed Pharmacy Practice Regulations-2015 seeks to widen the role of pharmacists by bringing uniform ethics code and also broadening their roles and responsibilities towards patients. These new regulations could boost the concept of community pharmacy in India. The new regulations could allow the pharmacist to review the patient’s medical history and doctor’s prescriptions. They can advise the patient in use of medicine and can take part in clinical decision making. The community pharmacy under the new regulations would also enable the pharmacists to take part in R&D, health awareness and promotional activities.
Various schedules under the Drugs and Cosmetics Rules, 1945
The Drugs and Cosmetics Rules, 1945 has provisions for classification of drugs into different schedules and also guidelines for storage, sale, display and prescription of drugs under each schedule. Major schedules are:
The drugs under this schedule can be sold only based on the prescription of a registered medical practitioner and only the amount specified in the prescription should be sold. It can be supplied only to licenced parties. These drugs should be labelled with the symbol ‘Rx’ and conspicuously displayed on the left top corner of the label.
Same rules are applied as per schedule H drugs. Here the drug retailer has to preserve the copy of prescription for two years and the drugs should be labelled with the symbol ‘XRx’ and conspicuously displayed on the left top corner of the label. Schedule X includes narcotic and psychotropic substances-based drugs.
This schedule was included in 2013 to check the indiscriminate use of antibiotics, anti-TB and some other drugs in the country. These drugs cannot be sold without a valid prescription. The package of the drugs will have a mandatory warning printed in a box with red colour border. The chemist should maintain the list of the customer names and details of the doctor who prescribed it. The list should be maintained with 3 years of data.