Drug Debate: Centre's reform on OTC drugs lacks teeth

Hyderabad: A separate category for the over-the-counter (OTC) drugs was created by the Centre though doubts persisted whether it would help curb abuse and misuse of antibiotics.

Experts said that while the move was to differentiate and create accessibility of drugs for minor illnesses, lack of awareness among the public is a concern. They also feared that it would help traders and pharmaceutical companies.

Over-the-counter drugs had no legal recognition in the country. All the drugs not included in the prescription list are considered OTC. Presently, drugs are classified as schedule X, H, H1, G and K which cannot be sold without a doctor’s prescription.

The government move was in the line with the US and was welcomed by the All-India Organisation of Chemists and Druggists Association. Its president, J.S. Shinde, said, “If there is a defined list of OTC drugs, there is going to be transparency. It will go a long way in controlling the abuse and misuse.”

There were suggestions that there must be proper labelling of the uses and also the manner in which the drugs had to be administered. A senior pharmacist, Dr Sai Kumar Katam, said, “The OTC drugs which are abused in India are cough and cold medicines, pain relievers and medicines for motion sickness. These have been found to lead to health problems like memory loss, kidney failures, heart problems and even death. Teenagers have been found to look for cheap and easy ways to get high by using DXM and codeine-based cough syrups which are purchased from local pharmacies. Given the Indian scenario, it is important to have a clear ground assessment before taking up separation of drugs.”

Senior pharmacist Dr Sanjay Reddy noted, “Awareness about medicines is not high in the urban and rural areas. Reading labels is not a habit and people blindly follow what doctors say. It is important to read labels. Also, there are drugs which require inputs from pharmacists before administration.

Given the history of abuse, it is first important to strengthen the pharmacy sector with qualified professionals. Ensuring strict regulation is important as it helps curb misuse.

The present set-up in states require inspectors for retail stores and pharmaceutical companies. It is to ensure that the regulation is properly implemented, the experts said.

A senior doctor, on condition of anonymity, said, “The government’s order on generic medicines has also remained on paper and its implementation is weak. Similarly, these policies without the right framework of regulations are merely going to be more of a paper work.”

The prescriptions are reused and people are unwilling to consult doctors repeatedly for the same problem. To add insult to the injury, there is huge consultation fee at hospitals.

Some commonly abused OTC medications include:

• Cough medicines (Dextromethorphan, or DXM), codeine-based cough syrups
• Cold medicines (Pseudoephedrine)
• Motion sickness pills (Dimenhydrinate)
• Pain relievers (Acetaminophen)

What goes into OTC category

• Categories with OTC potential in India would be: vitamins and minerals; health tonics, cough and cold; gastrointestinals; analgesics; dermatologicals; herbal/ayurvedic medicines, among others, which do not contain any substance listed in Schedules G, H or X.
• Commonly seen OTC drugs which are presently sold in India are:
• Cough/cold/fever: Corex, Chericoff, Lemolate, Avil, Deletus, Metacin, Calpol
• Headaches/body aches/sprains: Brufen, Combiflam, Voveran,
• Volini Skin ailments like acne, rashes, cuts and burns: Airol, Caladryl, Betadine, Candid, Flutivate, Soframycin
• Nutritional supplements: Becosules, Cobadex, Polybion, Shelcal, Protinex, Ferradol
• GI ailments like hyper acidity/constipation: Digene, Zinetac, Unienzyme, MPS, Lomotil, Dulcolax.
• Ayurvedic medicines: Vicks VapoRub, Amrutanjan Pain Balm, Zandu Pain Balm, Iodex
• Pain balm: Move pain cream, Itch Guard cream, Eno Fruit Salt antacid
• Drops: Halls lozenges, Dabur Pudin Hara, Calcium Sandoz etc. 

OTC drugs only for minor ailments
Over-the-counter drugs were only for minor illness like low-grade fever, cough, cold, headaches and loose stools. But for people suffering from co-morbid conditions like diabetes, heart diseases, cancers and other ailments, OTC drugs should not be taken even for minor illness.
Senior general physician Dr B Raju said, “Senior citizens, children, pregnant women and those suffering from co-morbid conditions can’t take OTC drugs as they have to consider the possible drug-to-drug and food-to-drug interactions. There have been cases where people have taken and it has resulted in complications.”
Doctors said possible contradictions were seen in these category of people for dosing errors and drug-alcohol interactions had been a major concern as it led to adverse reactions often resulting in emergency care or proved fatal.  OTC drugs for these category of people had to be taken only after consulting a doctor.