Unregulated sale of Schedule H drugs

Insight

All over Bengaluru, these medicines are sold over the counter —without doctor’s prescription

Four years after the Indian Pharmaceutical Association recommended that the sale of Schedule H drugs without prescription be restricted, they are still sold like over-the-counter medicines. Most pharmacies that Insight, IIJNM’s investigative magazine, visited, handed Schedule H medicines without asking for a prescription.

In 2014, The Indian Pharmaceutical Association (IPA) introduced a plan to the government regarding restricting the sale of Schedule H drugs over the counter. Schedule H drugs contain a list of drugs that can be sold only on the prescription of a registered medical practitioner. As per a March 16, 2006, notice by the department of health under the ministry of health and family welfare, there are 536 Schedule H drugs.

A general physician from Rajarajeshwari Nagar said: “All Schedule H drugs are not supposed to be sold without prescription, except for OTC (over-the- counter) drugs like cold medication and paracetamol. Antibiotics, diabetes drugs, anticonvulsants, sedatives and hypnotics should not be given without a doctor’s prescription. These medicines need doctor’s prescription before they are consumed because the patient may suffer from serious and unwanted side-effects. Most educated Indians do not complete the medicine course prescribed to them. All Schedule H drugs come with a red line on the cover. One major problem is that the government supports non-allopathic practitioners who prescribe allopathic medicines without proper dosage or proper duration. Only certified pharmacists should dispense these drugs as per the rules.”

Om Sri Maruthi Medical & General Stores in Rajarajeshwari Nagar have this reporter azithromycin tablets, used to treat bacterial infections, without a prescription.  When asked for a bill, the pharmacist wrote a doctor’s name.

The Pharmacy Act, 1948, states that a pharmacist must hold a degree or diploma in pharmacy or pharmaceutical chemistry, or a chemist and druggist diploma of an Indian university or a state government.

Under the Pharmacy Act, a statutory body called the Karnataka State Pharmacy Council was constituted. The pharmacists’ oath states that the pharmacist shall follow the system which they consider best for pharmaceutical care and counselling patients.

Padma Medicals in Indiranagar sold Azax 500mg Tab (azithromycin) without demur. When asked for a bill, the pharmacist asked for the doctor’s name. He wrote on the bill the made-up name provided by the Insight reporter.

MedPlus pharmacy on New Thippasandra Main Road sold amoxicillin, an antibiotic and Schedule H drug, without a prescription. Amoxicillin is used to cure various types of bacterial infections such as bronchitis, pneumonia, gonorrhoea, and infections of the ear, nose, throat and urinary tract. There was no pharmacist at the store.

After making the purchase, this reporter asked the person at the counter how he sold a Schedule H drug without a doctor’s prescription. He replied that most customers don’t bring a doctor’s prescription.

Fortis Pharmacy outside Fortis Hospital at Cunningham Road refused to sell diazepam, a Schedule H drug used to treat anxiety disorders, alcohol withdrawal symptoms or muscular spasms, without a prescription. The pharmacist suggested this reporter go to any other pharmacy because it would be easy to get it without a doctor’s prescription there.

It was very easy to buy amoxicillin at the pharmacy attached to Primecare Multispecialty Clinic in Fraser Town.

Cash Pharmacy, at the junction of St Marks Road and Residency Road, was ready to sell – without a prescription – ciprofloxacin, an antibiotic used to treat urinary tract infections, acute uncomplicated cystitis in women, and other conditions. The side-effects of consuming this medicine are nausea, headache, vomiting and rash.

Dr Ramanand T, a general physician, explained there are certain drugs which should not be given without a valid prescription by a doctor. For example, Restyl tablet, a sedative. These drugs are dangerous because they can be misused by people who want to commit suicide. When a person takes an overdose of such tablets and dies, the pharmacist who sold them is questioned. If it emerges that the pharmacist sold the medicine without a doctor’s prescription, his licence is cancelled. “These days, doctors are very careful while prescribing drugs. They don’t prescribe more than two or three medicines so that there is no misuse by the patient.”

Jaivardhan Jeph, who practices in the Delhi High Court, said: “In India, the sale and purchase of drugs are mainly regulated by the Pharmacy Act, 1948, which is only a regulatory Act and sets guidelines to be followed by all pharmacies. The second is Drugs and Cosmetics Rules, 1945, which contain provisions for classification of drugs under given schedules… there are guidelines for the storage, sale, display and prescription of each schedule.”

Jeph added: “We can clearly see that the present laws are unable to tackle the growing problem of substance abuse, and sale of drugs without prescription. Both state and central governments should formulate plans and create a strong law regarding the same.”

Dr Mukesh T, an orthopedician at Sparsh Hospital, said Schedule H drugs are those drugs which are not available over the counter. In orthopaedics, codeine and morphine, used for pain relief, are habit-forming.

“Once patients have these drugs, they feel like having them again and again. It gives them a feeling of goodness. The patient does not feel pain anymore, and feel high in a different sense. That is the reason why these medicines are not available over the counter. Pharmacists in India sell Schedule H drugs without insisting on a doctor’s prescription. This should be stopped,” Dr Mukesh added.

A lawyer who practices in the Gujarat High Court said the existing regulatory framework regarding the sale of Schedule H drugs without prescription is loosely regulated. India lacks strict laws to curb such sales. Judicial intervention is called for. Recently, the Bombay High Court cancelled the licences of chemists who sold Schedule H drugs without prescription.

Dr Karthik, a pharmacologist, conceded that at many pharmacies Schedule H drugs are sold over the counter. This can lead to adverse effects for the patients. As per the Drugs and Cosmetics Rules mentioned in Central Drugs Standard Control Organization (CDSCO), Schedule H drugs will not be sold without the prescription of a registered medical practitioner.

At Frank Ross Pharma, Malleswaram, the pharmacist sold Lobazam tablets, used to control seizures. He refused to give a bill because there was no prescription. He later agreed to make a bill when this reporter offered to provide a doctor’s name..

Jeph said: “The punishment in India for selling drugs without prescription is termination of licence of the particular pharmacy through the judicial process, but the matter reaches there very rarely. It is very important to evolve a new mechanism so that lives can be protected”

The Indian Pharmaceutical Association was not available for comment.

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