India’s image as pharma hub at stake

In the past month or so, we have witnessed two unfortunate incidents involving unexpected deaths which are suspected to have been caused by the use of contaminated medicines. In September, Chandigarh-based PGI had reported that the use of propofol, a safe anaesthetic agent, resulted in the death of five patients. An investigation is underway into the possibility of contamination of the batch of propofol which was used. Initial reports by the regulatory authorities do indicate that the drug used failed the quality test. The authorities concerned in Himachal Pradesh have ordered the withdrawal of all batches of propofol and directed the company making the drug to pause its manufacture.

Early this month, the World Health Organisation (WHO) announced the deaths of 66 children in Gambia following the use of some cough syrups. Unfortunately, there was an Indian connection in this instance as well — the cough syrups used appear to have been manufactured/supplied by an Indian pharmaceutical firm. The matter is currently pending investigation by the Indian authorities. It is feared that the glycerine (propylene glycol), which was used in the manufacture of the cough syrup, may have been contaminated with diethylene glycol (DEG) and ethylene glycol (EG), which are extremely harmful to the kidneys and can be fatal. DEG and EG are cheaply available, and the urge to cut costs and boost profit margins could tempt manufacturers to mix these compounds in glycerine which is used as a sweetener in cough syrups. The cough syrups involved in the Gambia incident are reported to be glycerine-based solutions.

A similar case had earlier been witnessed in 2020, when a cough syrup contaminated with DEG and EG resulted in the deaths of children in Udhampur, Jammu and Kashmir. In that instance, the issue was flagged by the faculty at PGI, Chandigarh.

It is only after the completion of the investigation into these recent cases that the whole truth will be known. In the event of culpable negligence or deliberate wrongdoing is found, it will reflect a truly sad and miserable state of affairs. Unscrupulous and unethical manufacturing practices, perhaps motivated by human greed, would have transformed healing and life-saving medicines into life-taking poisons.

Another matter of serious concern is the manufacture of substandard preparations, which also seriously compromise medical treatment. This is a serious hazard, and is possibly widespread.

Given the gravity of the problem, the Government of India has been constituting committees to look into the issue and suggest remedial steps. One such committee, set up in 2000, was headed by Dr RA Mashelkar, one of India’s leading scientists. The committee was given the responsibility of examining various aspects of the problem, including the regulatory infrastructure, and giving its recommendations with a road map for their implementation. The committee submitted its report in 2003. It concluded that the existing regulatory framework was quite inadequate and weak. It highlighted, in particular, inadequate infrastructure in the form of testing facilities and the lack of specially trained cadres. It recommended that a strong, well-equipped and professionally-managed Central Drugs Standard Control Organisation (CDSCO) was absolutely necessary, and it would have to be supported by the states. The recommendations of this committee are yet to be implemented in letter and spirit. Even today, the state of affairs is quite dismal, and the shortage of surveillance and testing facilities continues. The limitations and shortcomings in the regulatory system continue to persist, and the recent incidents have once again exposed our regulatory weaknesses.

Our pharmaceutical sector is counted as one of the success stories of Indian manufacturing. The Indian pharmaceutical industry is the third largest in the world. It is the biggest supplier of generic drugs particularly in the critical areas such as HIV/AIDS and life-saving vaccines. Generic drugs, owing to their low prices, are vital for developing nations and have tremendously benefitted the world. However, the dishonest or negligent acts of some people among the manufacturers tend to tarnish the industry as a whole. Such repeated incidents raise doubts about the quality of our products as well as the efficacy of the regulatory system and our willingness to learn necessary lessons. In the process, human lives are put at risk and public confidence in the healthcare system as a whole is shaken.

Additionally, India’s name in the world at large is sullied, as is its reputation as an emerging manufacturing and industrial powerhouse. India is the largest exporter of generic drugs particularly to the under-developed nations, and we can ill-afford such unacceptable lapses, given the highly competitive nature of the market.

Such instances of negligence or wrongdoing in the manufacture of drugs are completely unacceptable. Spurious drugs (whether contaminated or substandard) usually result from negligent lapses, or deliberate wrongdoing, during the manufacturing practices. There is an urgent need to have a relook at our extant policy guidelines, and to bolster the enforcement process. Adequate infrastructure in the form of testing facilities manned by fully trained professionals must be ensured. Strict monitoring of the existing statutory and other safeguards is vital. The legal and regulatory regime should be so structured as to encourage voluntary compliance and self-regulation, while possessing the teeth and the will to deal with the deviant cases with a heavy hand.

There is also a need to strengthen our drug alert and pharmacovigilance programmes. These are ways to ensure the safety of our products post-marketing. Any further action following such drug alerts, resulting in a recall of the drugs, must be put in the public domain at the earliest.

It is vital that the consumers of Indian pharmaceuticals in the country and abroad are reassured that the drugs available in the market are safe and effective. By strengthening our resolve and taking necessary measures in right earnest, we can win the confidence of the consumer and hope to eradicate the menace of spurious drugs. We are considered the pharmacy of the world for generic drugs and can’t afford to lose this position and opportunity.