The drug products safety, quality and efficacy has repeatedly been the most talked-about topic in the pharmaceutical space. To be approved for marketing, it is mandatory to prove that a drug is safe, effective and of highest quality for human use. Even after the drug is approved for marketing, manufacturers must produce phase IV reports, that is the pharmacovigilance reports, to ensure that the drug products are safe, effective and of highest quality.

In India, the CDSCO (The Central Drugs Standard Control Organisation under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India), along with the help of Indian Pharmacopoeia Commission (IPC) and State Drug Control (SDC) Authorities ensure that the public is subject to high quality drug products.

In this regard, most recently, the IPC revealed an Adverse drug reaction (ADR) related to Mefenamic Acid in its November monthly safety alert report. This ADR is a drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, which can be life-threatening.

Mefenamic acid is used as a pain reliever for conditions such as menstrual cramps, rheumatoid arthritis, osteoarthritis, dysmenorrhoea, inflammation, fever, and dental pain.

The branded products – Meftal and Meftal Spas are widely used by women to curb the pain associated with menstrual cramps and are oftem sold as Over-the-counter (OTC) drugs. This alert was issued in response to initial review of the drug reactions in the Pharmacovigilance Programme of India (PvPI) database and it cautions the use of Mefenamic acid while monitoring for the ADRs. However, the drug is in no way completely banned. This is a good example of how government continues to monitor the safety associated with drugs that are already on the market.

The Indian government also strives hard to monitor the therapeutic efficacy or therapeutic value additions of the drugs that are on the market. In 2023, the Union Health Ministry banned 14 fixed-drug combinations (FDCs) post the flagging by Supreme Court. These 14 FDCs are:

1. Nimesulide, paracetamol dispersible tablet
2. Amoxicillin, bromhexine
3. Pholcodine, promethazine
4. Chlorpheniramine maleate, dextromethorphan, guaiphenesin, ammonium chloride, menthol
5. Ammonium chloride, bromhexine, dextromethorphan
6. Chlorpheniramine maleate, codeine syrup
7. Bromhexine, dextromethorphan, ammonium chloride, menthol
8. Dextromethorphan, chlorpheniramine maleate, guaiphenesin, ammonium chloride
9. Paracetamol, bromhexine, phenylephrine, chlorpheniramine, guaiphenesin
10. Salbutamol, bromhexine
11. Chlorpheniramine, codeine phosphate, menthol syrup
12. Phenytoin, phenobarbitone sodium
13. Ammonium chloride, sodium citrate, chlorpheniramine maleate, menthol syrup
14.  Salbutamol, hydroxyethyl theophylline, bromhexine

These were banned under Section 26A of the Drugs & Cosmetics Act, 1940 with the reason that there was no therapeutic justification for these FDCs and involved a risk to human beings.

Thus, in the recent years, government have been very cautious of the safety and efficacy issues related to the drugs on the market. However, more monitoring is needed in this space. There have been reports flagged on a global level on the drugs manufactured in India that have caused severe harm and a dozen of deaths across the world. The latest on the news was the deaths of two Sri Lankan patients who were given anaesthetic drugs manufactured in India. Also, in May 2023, an eye drop that was manufactured in India caused eye infection in 30 and blindness in 10 patients in Sri Lanka. Many such reports have been found out and linked to Indian-made drugs by World Health Organisation since a few years now.

These incidents raise serious questions and reflect an enhanced need to monitor the drugs on the market while taking serious actions on substandard drugs.

Some of the ways India can improve upon include:

1. Increasing transparency: Currently, there is no searchable database in India that captures the list of approved drug products along with their labels. It becomes very difficult to monitor the brands and generics on the market and thus, becomes difficult to curb the distribution of substandard drugs.

2. Enhancing accountability: There are pharmaceutical companies in India that do not adhere to the good manufacturing practices, resorts to illegal practices, falsify data and much more. Adding mechanisms in place to increase the accountability of such manufacturers can also help distribution of only safe medicines of highest quality on the market.

3. Increased scope of regulations: the Drugs and Cosmetics Act of 1940 needs to be amended to cover complex aspects of clinical trials, bioequivalence studies, good manufacturing practices and more. The enforcement of this act needs to be strengthened since the pharmaceutical distribution is often fragmented, complex and involves many authorities at Central and State level.

4. Better infrastructure: the lack of high-quality labour and infrastructure is yet another reason that may compromise the drug quality. Government has various schemes in place to help manufacturers in this regard. However, lack of awareness, hesitation and illegal activities may cause hindrance in making the most of these schemes.

5. ADR reporting: There is a need pf increasing awareness amongst the public related to ADR reporting. It has also been observed that, although aware, there is always a hesitancy in reporting ADRs to the government.

India is world’s largest generic manufacturers. It caters up to 20% of world’s generic medicines needs. Thus, it is very crucial for the drugs manufactured in India to be of utmost safety, efficacy, and quality. The drug safety alerts and bans are a good way forward but there is a wide scope of additional efforts from public, manufacturers, and government to help commercialization of only safe and effective medicines.

References:

1. https://www.ipc.gov.in/images/Drug_Safety_Alert_November_2023.pdf
2. https://drugs.delhi.gov.in/sites/default/files/drugs/circulars-orders/prohibition_of_14_fdc.pdf
3. https://www.google.com/amp/s/www.thehindu.com/opinion/editorial/safety-first-on-indian-pharma-products-and-drug-safety/article66986273.ece/amp/