The government order requiring that cough syrups be sold only on a doctor’s prescription is a welcome intervention to address the threat of poisoning from contaminated syrup-based medicines. Cough syrups have been removed from Schedule K, which earlier allowed them to be sold even in general stores in villages, and over-the-counter sales from pharmacies have been prohibited. They can only be sold from licensed pharmacies on a valid medical prescription. Cough syrups have caused deaths and sickness, especially among children, as they were readily available as popular medication. Many deaths have been reported from within India and from other countries where the syrups were exported.
Last October, 22 children died after consuming cough syrups in Chhindwara, Madhya Pradesh. There were many other cases of deaths from different states. Cough syrups exported from India were linked to the deaths of dozens of children in Gambia, Uzbekistan, and Cameroon. The World Health Organization (WHO) has issued an alert about Indian cough syrups. Many people consume cough syrups without understanding the risks. Making a doctor’s prescription mandatory might help to curb sales, but such rules are commonly flouted. The order does not address the real problem at the manufacturing stage, where the syrups are contaminated with dangerous chemicals. There are no effective safety regulations and guidelines, and an efficient system for monitoring and supervision of processes.
The statutory mechanism for quality control and inspections does not work for various reasons, including lack of necessary infrastructure, facilities and manpower, loopholes in the legal framework, delays in the working of the system, and corruption and malpractices. Cases are forgotten soon, and erring units come back into business. Penalties and other punitive actions are often reversed on various grounds. Even after incidents of contamination become public, cough syrups made by the same company continue to be available in the market.
The solution to the problem must begin at the source, not at the point of sale. There are over 2,000 cough syrup manufacturers in India, including major pharmaceutical units and small and third-party units. It must be ensured that they follow the right processes, backed by a rigorous regime of testing, monitoring, and quality assurance. Rules demand that the raw materials and every batch of the product should be tested for their quality, but that is not done. The responsibility for the implementation of the rules and regulations rests with the state agencies and regulatory bodies in the sector. There is no effective co-ordination between central and state agencies in the field. Unless these weaknesses are addressed, a restriction at sales points will not achieve the intended results. (Source: DH)
