Explainer: Increasing number of substandard medicines in the market, Delhi-Chennai are big centres, can even cause death, what is the punishment

After investigation, Drug Controller General of India (DGCI) found that 50 medicines being sold in the country are of substandard quality. People are consuming these. These include medicines from paracetamol to BP, cough, multivitamin and calcium. These are used by lakhs of people. The network of substandard medicines is spreading in the country. We will tell you what harm it causes and which places are its strongholds. Not only this, why such medicines are more available in the village market. What is the law for this and what action can be taken.

India is a major global supplier of generic medicines. It is estimated that 12-25% of the medicines being produced may be adulterated, substandard or counterfeit. The Central Drugs Standard Control Organisation (CDSCO) has identified more than 50 commonly used drugs that do not meet quality standards.

In how many categories are substandard medicines divided
Substandard drugs are classified under the Drugs and Cosmetics Act 1940, which defines them as misbranded, counterfeit or adulterated. The CDSCO classifies these into three categories based on severity.
Category A: Counterfeit and adulterated drugs
Category B: Extremely substandard drugs that fail the compound test or contain less than 70% active ingredients
Category C: Minor defects such as minor changes in labeling or formulation.

What does the quality control report say?
A recent report indicated that more than 15% of the medicines produced by small companies failed to meet quality standards while the national average is around 2%. They have a huge market. The medicines in the village market are from small manufacturers. Their quality is generally low.

Where are the most substandard medicines being sold
1. Delhi – A pilot study showed that 12% of the drug samples tested in Delhi were substandard.
2. Chennai – According to the same pilot study in Chennai, the incidence of substandard medicines was found to be 5%.
3. Maharashtra – Maharashtra is identified as the biggest hotspot for fake and substandard medicines. Reports from previous years have revealed that the state had the highest number of cases related to poor quality medicines, especially in urban centres.
4. Kerala – Recent assessments have revealed a high prevalence of substandard medicines in Kerala as well. The state is being described as a leading manufacturer of such medicines.
5. Uttar Pradesh – Uttar Pradesh also faces significant challenges regarding the quality of healthcare, including the prevalence of substandard medicines.
6. Bihar – Bihar is another state with a high burden of health expenditure, with out-of-pocket expenditure accounting for a significant portion of the total healthcare cost.

What is the situation in rural areas
Rural areas face greater challenges of substandard medicines. A 2022 report found that more than 15% of medicines produced by small manufacturers failed quality tests, while the national average is 2%. Small drug manufacturers focus more on rural markets. There is also not much monitoring of the quality of medicines there.

Death by substandard drugs
– Substandard medicines pose a serious threat to public health, causing a wide range of adverse effects
– Sometimes it creates a poison like situation, which becomes very dangerous for the body
– Substandard drugs may contain toxic doses of dangerous ingredients, leading to mass poisoning and even death. For example, a substandard version of the diabetes drug glibenclamide sold in China contained six times the standard dose, killing two people and making many others sick
– Poor quality medicines affect the treatment of serious, chronic and critical diseases, thereby worsening the disease
– Poor quality medicines lead to drug resistance and can lead to death. This also makes the medicines stop working.
– The circulation of substandard medicines undermines people’s confidence in the health system and its legitimate health care professionals.

what is the punishment for this
The Drugs and Cosmetics Act 1940 prescribes punishment for offences relating to substandard drugs in India.
– Fake and adulterated drugs carry a minimum imprisonment of 10 years, which can be extended to life imprisonment.
– Punishment for minor substandard drugs is 1 year imprisonment which may extend to 2 years

Does the Public Trust Bill lighten the punishment
A recent amendment to the Jan Vishwas Bill allows “combining” of punishments for drugs not of standard quality (NSQ) under Section 27(D). This means manufacturers can pay a fine instead of facing imprisonment for the first offence.
The government claims this will reduce harassment of law-abiding businesses, while critics argue it trivialises the issue of substandard medicines that pose serious health risks.

Tag: drugs problem, generic medicines