- According to a direction issued, the Ministry of Health and Family Welfare has prohibited the manufacture for sale, sale or distribution for human use of 328 Fixed Dose Combinations (FDCs) with immediate effect, it also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions.
What are Fixed Dose Combinations (FDCs) drugs?
- FDC drugs contain two or more active ingredients in a fixed proportion.
- The proportion is in accordance to the most prescribed dose of the independent ingredients.
- For example, it is usual to combine Paracetamol with Ibuprofen. The first one is an analgesic and anti-pyretic while the latter is a non-steroidal anti-inflammatory drug (NSAID). The combination is considered beneficial in cases of acute pain of several types such as toothache, body ache etc.
- Similarly, statins (a class of cholesterol lowering drugs) are frequently combined with angiotensin-converting enzyme (ACE) inhibitors such as Ramipril. The combination is considered to be cardio-protective.
Why FDCs are banned?
- The ministry had considered the recommendations of Drugs Technical Advisory Board (DTAB) and an expert committee it had set up a few years ago to look into the safety and rationality of these medicines.
- The ministry’s decision was taken after its Drugs Technical Advisory Board (DTAB) said the ingredients of these FDCs have no therapeutic justification and they may be risky to consume.
- Also, Kokate committee, which studied the irrationality of various FDCs, recommended the ban on 344 of them, citing the rising antibiotic resistance in the country as one of the reasons.
What is antibiotic resistance?
- Antibiotic resistance is the ability of a microorganism, which is causing the disease, to withstand the effects of an antibiotic medicine.
- Government following the recommendation of the Kokate committee banned 344 fixed dose combination medicines. Subsequently, the government had prohibited five more FDCs in addition to the 344 under the same provisions.
- Under Section 26A of the Drugs Act, a drug can be banned only after the licence holder of that drug is given a three-month notice.
- Later in December, 2016, Delhi High Court struck down the ban stating that the government had acted in a “haphazard manner”.
- However, the matter was contested by manufacturers in various High Courts and the Supreme Court.
- The Supreme Court had directed the health ministry’s expert body, Drugs Technical Advisory Board (DTAB), for a fresh review of safety, efficacy and therapeutic justification of these 349 FDCs.
- Therefore, the DTAB formed a sub-committee, which studied the issue and submitted its recommendation.
- After reviewing 349 fixed drug combinations (FDCs), the panel recommended that 343 of them should be “prohibited” and the remaining six should be “restricted or regulated”.
- The health ministry pruned a list of banned combination medicines and added restrictions to the dosages or uses for six more types of such drugs.
- The ban on 328 such drugs, compared with 344 earlier and is effective immediately and may shave off over Rs 1,500 crore from India’s Rs 1.18 lakh crore pharmaceutical industry.
Advantages of FDCs
- FDCs usually have lower costs of manufacturing compared to the costs of producing separate products administered concurrently
- They also have simpler logistics of distribution
- FDC drugs ensure cheaper prices, convenience to the patients, improved patient adherence and reduced development of resistance in the case of antimicrobials
- These are particularly useful in the management of HIV/AIDS, malaria and tuberculosis, which are considered to be the foremost infectious disease threats in the world today.
Problems associated with FDCs:
- The side-effects of the combined product and its effects are different from those of its individual components.
- When an adverse reaction happens in a patient, it is often difficult to place which ingredient is responsible for that reaction.
- Independent studies conducted across the world that have pointed out that many of these combinations do not have any advantage over the individual drugs. For example, a study published in the Indian Journal of Pharmacology in 2010 found, “Nimesulide and paracetamol combination offers no advantage over nimesulide alone or paracetamol alone, either in terms of degree of analgesia or onset of action.”
- FDCs promote irrational drug use. Injudicious use of antibiotic FDCs can rapidly give rise to resistant strains of organisms, which is a matter of serious concern to the health care situation in our resource poor country.
- Irrational FDCs also impose unnecessary financial burden on consumers.