Problems with the availability of narcotic medicines

In December 2004, the Maharashtra State Chemists and Druggists Association issued a circular (1) telling their members to keep records of every tablet, injection, capsule and syrup of all psychotropic substances and antidepressants marked as ‘Nrx: Much has appeared in the press since then on the non-availability of life-saving medicines without prescriptions. Patients questioned pharmacists’ integrity. The Food and Drug Administration (FDA) was held responsible for patient unfriendly rules. We decided to investigate the subject.

The Narcotic Drugs and Psychotropic Substances (NDPS) Act (2) was enacted in 1985 to regulate the manufacture, sale, purchase, stock and use of narcotic or potentially addictive drugs. These drugs, which are listed in a schedule (3), may be dispensed only upon prescription. They are used for chronic conditions such as depression, anxiety, tension, psychosomatic and behavioural disorders, and are used for long durations, usually life-long. Since these drugs can be misused (4) their use must be monitored stringently. The Act specifies that pharmacies selling these drugs must maintain a record of all sales. Failure to produce complete records can lead to a heavy penalty and even imprisonment.

When the Act was first enacted, doctors were expected to write triplicate prescriptions with one copy for their records, the second for the pharmacy and the third for the patient. Patients had to go back to the doctor for refill prescriptions every time. The rules were cumbersome but were followed.

Over the years, this practice fell into disuse. Prescriptions were filled by the pharmacy and handed back to the patients. Eventually many scheduled drugs started getting dispensed without a prescription to friends, known regular patients and on special requests. We can easily imagine how such sales were accounted for and where the profits from such sales went. This holds equally true for private and public sector pharmaceutical companies. If the drugs were sold without bills there was no tax paid. Pharmacists, druggists and the authorities all have tar on their hands.

It is believed that the Narcotic Bureau woke up after a big haul of illegal stock of these medicines. Subsequently, it decided to enforce existing regulations.

In December 2004 the Nagpur District Chemists and Druggists Association (NDCDA) informed its members (1, 6) that the Narcotics Bureau was harassing distributors, stockists and retailers and issued instructions to sell Schedule Nrx medicines only to regular customers whom they could identify- it did not mention the need for a proper prescription. This instruction added to the plight of patients suffering from chronic illnesses, who had been getting these essential drugs conveniently from pharmacies. The NCDA’s action was condemned in the press (5). In several instances pharmacists refused to sell narcotic drugs even on a valid prescription.

The enforcement of existing rules is for the good of everyone. But this should have been done slowly so that patients were prepared, and had proper prescriptions in hand. Pharmacists are expected to be aware of the rules but unfortunately even doctors prescribing these drugs are ignorant of the rules.

Instead, the NCDA demanded that narcotic drugs be removed from the purview of the Narcotics Drugs Act and placed under the scope of the Drugs and Cosmetics Act. The authorities gave an assurance that the list of psychotropic substances covered by the Narcotics Act would be reduced. This would mean that fewer Nrx medicines would be monitored, and therefore easily available for abuse.

On February 25,2005 Rule 67 of the NDPS Act was amended and is no longer applicable to those who have a license to sell drugs under the Drugs and Cosmetics Act.

Effectively, pharmacists put chronically ill patients to inconvenience and then appealed for a relaxation of existing rules. This is a crooked way of getting thhgs done. Regulatory authOrities are not in the wrong here. And nor should patients be blamed for their ignorance of the rules.