Cough syrup tragedy: Lessons learnt!

The Diethylene Glycol (DEG) poisoning occurred from using contaminated cough syrup has already claimed twenty four children in several states in India.  The blame game continues accusing from one to the other as responsible for this tragic incident It is not that the DEG poisoning occurred for the first time, the first incident occurred in America in 1937 when a company used DEG as solvent for preparing sulfanilamide elixir in an attempt to develop paediatric product as it was not soluble in water. Unfortunately, more than one hundred children lost their lives before the product was withdrawn. This unfortunate incident led to enactment of Federal Food, Drugs and Cosmetic Act of 1938 and creation of FDA to administer and enforce the Act. The DEG poisoning continues to be an issue in India despite several poisoning cases reported over the years and no major initiatives taken to prevent similar occurrence. Fortunately, at this time India seems to have awaken and something to be done is in everybody’s mind from manufacturer to regulators. We have been always reactive rather than proactive.

Let us look into the few serious issues involved in this case. The company is given manufacturing licence by the Tamil Nadu government but the products are used in other states. The other state’s concerned authority writes back to Tamil Nadu authority seeking help. That means the authorities are different when handling. Madhya Pradesh government formed special investigating team (SIT) to look into the whole issue of cough syrup related deaths. The different state governments have different capacities both in terms of adequacy number of officers and their capacity to implement the provision of the Drugs and Cosmetics Act. Though, the regulatory mechanisms are based on the same act but implementation is different. The drug regulatory authorities failed to monitor the activities of the firm. It has been reported that the manufacturing pharma of this killer pharma was not inspected for over a decade or so. The inspection is a monitoring mechanism. Are our regulatory officials have no SOP? When we insist of compliance of SOP in manufacturing and quality control, why can’t we have SOP for regulatory officials. The periodic monitoring of the regulators’ activities improves the effectiveness of mechanism. Perhaps making these SOPs mentioned in website would bring better accountability.  

Another important issue is the rational use of drugs. Union Health Ministry has advised that cough and cold medications should not be prescribed or dispensed to children below two years. In an advisory, the Ministry said, these are generally not recommended for children below five years, and above that, any use should follow careful clinical evaluation with close supervision. If this is so why was the government silent over all the years.  It is not to take the matter as reactive and issue advisory note for cough syrups. All medicines should be used rationally and strategies to be initiated to promote such activities.  The Central Drugs Standard Control Organisation (CDSCO), the national drug regulatory authority, is helpless as manufacturing and sales of medical products fall within the domain of state governments. It is time empower CDSCO to fulfil its mission “To safeguard and enhance public health by assuring safety, efficacy, and quality of drugs, cosmetics and medical devices”. Empowering CDSCO is not easy as it requires change/amendment of statute. When the country is progressing towards achieving One Nation and One Regulation, this may not have much difficulty, but definitely challenging. 

The CDSCO was unaware of the existence of the Sresan Pharma, the tainted company who manufactured the killer syrup. That shows the status of our national drug regulatory authority. Its very purpose is under threat as no one wants to comply with its directive. The biggest challenge the state drugs control authorities are not under the administrative control of national authority. Both the authorities, National and State, work with the provision of Drugs and Cosmetics Act 1940 and the Rules 1945. The provisions were made looking at the situation of the period. We are now with the brand “India is the Pharmacy of the world” means we have come in a long way from depending on import to Atmanirbhar Bharat, meaning "self-reliant India". But regulations should also to be revised matching with current need. The country has replaced many of the colonial period legislation with new ones. Drugs and Cosmetics Act is waiting for its turn. It is a public health legislation and should receive priority attention. CDSCO has initiated the data base of not of standard quality (NSQ) drugs and urged the state authorities to submit their data. The data of August 2025 shows that 15 states and 5 union territories have not complied with CDSCO’s directive. A good initiative is losing its relevance. 

Good Manufacturing Practices (GMP) is the foundation for ensuring quality of medicinal products. On 28th December, 2023, the Government of India had notified revised GMP (schedule M of Drugs Rule). The government’s own admission is the revised Schedule M requirements are a positive step towards ensuring the quality and safety of pharmaceutical products being manufactured in India. Unfortunately, we continue to extend time frame for implementation. Government’s new directive is in respect of small and medium manufacturers having turnover of Rs. 250 crores or less, is given time up to 31st December, 2025 to comply. During this period, we have two categories of pharmaceutical industries: one GMP compliant and one without GMP compliance. The label of the product does not mention about this. Next comes the price of medicines manufactured whether there is differential pricing system. It is publicly not known about the prices of medicinal product manufactured by small and medium sectors. Coming to quality of the pharmaceutical products we have two qualities: quality products available by GMP compliant and GMP non-compliant units. The public believes all products available in the market or public health facilities are of same quality. We must remember unlike other consumer goods the general public has little choice on medicines. 

Pharmaceutical education needs to focus on these historical tragedies to sensitize the students, the future professionals. We always teach the students what they should use in formulating medicinal products but never insists on what they should not do. This incident is an example in that way. The classic example that has been used to sensitise and educate the students, if a surgeon commits a mistake one patient will die but when pharmacist makes a mistake in manufacturing, it may cause several deaths. The learning of the students would have more sustaining effect.  Many initiatives are made to promote business activities like changing some provisions of regulations. The doing business like manufacturing and selling medicines require more stringent provision to discourage people from doing wrong things in public health interest. 

Conclusion
The experiential form of learning is more effective and sustainable. The time has come for the country to take this example for making better provisions ensuring medicines safer for use. We need to be proactive but not just reactive like fire fighting!