Year : 2016 | Volume
: 2 | Issue : 1 | Page : 1--2
Steroid containing fixed drug combinations banned by government of India: A big step towards dermatologic drug safety
Department of Dermatology, NKP Salve Institute of Medical Sciences, Lata Mangeshkar Hospital, Nagpur, Maharashtra, India
Department of Dermatology, NKP Salve Institute of Medical Sciences, Lata Mangeshkar Hospital, Digdoh Hills, Hingna, Nagpur - 440 019, Maharashtra
|How to cite this article:|
Pande S. Steroid containing fixed drug combinations banned by government of India: A big step towards dermatologic drug safety.Indian J Drugs Dermatol 2016;2:1-2
|How to cite this URL:|
Pande S. Steroid containing fixed drug combinations banned by government of India: A big step towards dermatologic drug safety. Indian J Drugs Dermatol [serial online] 2016 [cited 2021 Oct 19 ];2:1-2
Available from: https://www.ijdd.in/text.asp?2016/2/1/1/184102
The Director General of Health Sciences (DCGI), Ministry of Health and Family Welfare of the Government of India through Gazette notification on March 10, 2016, has issued the order that certain fixed-dose combination (FDC) of drugs has the potential to cause a risk to human beings and the said drugs were found to have no therapeutic justification. Whereas safer alternatives to the said drug are available, an expert Committee appointed by the Central government recommended by the way of prohibition of manufacture for sale, sale and distribution for human use of the said drug in the country. The Central government exercising its powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), prohibited the manufacture of certain FDCs with immediate effect. This is a very important development in the Indian regulatory front which will impact in a greater way to check rampant and indiscriminate use of certain FDCs in a clinical practice in India. As far as dermatology practice in India is concerned, this is a good step toward achieving the goal of better drug safety and improving public health.
Out of many fixed-drug combinations banned as per the above order, certain FDCs are of immense relevance to dermatology practice in India. These include FDCs consisting of potent topical corticosteroids such as clobetasol or betamethasone or fluticasone, in combination with antifungal agents such as miconazole or clotrimazole or tolnaftate added with topical antibacterial agents such as gentamicin, neomycin, nadifloxacin, and fusidic acid. Sometimes, compounds such as lignocaine, zinc sulfate, and lodochlorohydroxyquinone were added to the above combination without any rationale. It is surprising how these combinations were permitted in the past without adequate clinical trials. In the initial years of the development of dermatology specialty in India, the combinations were used by physicians or general practitioners (GPs) when etiology of the majority of skin diseases was not properly understood and no effective and specific drug was available. However, due to extensive research and experience of dermatology experts all over the world and in India, our understanding of skin diseases has changed significantly. This has resulted in the use of a specific drug for a specific skin disease. Simultaneously, pharmacological industry all over the world was successful in bringing many molecules for various dermatology indications through extensive clinical research and trials. Considering these developments, a majority of dermatology practitioners in India has switched to the use of single therapeutic agent rather than the use of combination drugs. This has resulted in the improvement of skin health in general and the cure of skin diseases in particular. However, a majority of GPs in India and a selected number of nondermatology physicians continued to use FDCs due to a lack of understanding of basic knowledge of dermatology diseases and treatment. In the pursuit of producing temporary and rapid results, these FDCs consisting of potent topical corticosteroids were rampantly used by GPs. This has resulted in a lot of side effects and has caused an immense loss to a vital and the largest organ of the human body, i.e., skin. Local side effects included irreversible or permanent local skin atrophy, telangiectasia, purpura, striae, hypertrichosis, acneiform eruptions, secondary bacterial or viral infections, perioral dermatitis, and hypopigmentation. In addition, irrational use of topical steroids containing FDC has also resulted in various systemic side effects (glaucoma, hypertension, hyperglycemia etc.). Treating fungal infections has become a therapeutic nightmare due to the indiscriminate use of topical corticosteroids, which is leading to rapid resistance to current antifungal drugs.,
A study was done by a group of investigators in India which included 85 patients of dermatophytosis who were treated with steroid-containing FDC. They concluded that 90% of the patients were found to be resistant to terbinafine, a key anti-fungal agent that was used for a long time for the treatment of superficial fungal infection with successful results (personal communication). This cites an adverse role of steroid-containing FDC in the development of resistance to a number of current generation of antifungal agents. Such harmful FDCs were also dispensed by pharmacists all over India without prescriptions by a qualified dermatologist or a doctor. As it has produced temporary but rapid benefits, self use or abuse of these FDCs spread like a wild fire! Pharmaceutical companies in India brought many such formulations with multiple ingredients for monetary benefits without considering the impact of such practices on the health of an individual. The market for steroid or steroid-containing creams is huge. According to the IMS health agency, topical steroid sale for 2013 at the end of December stood at Rs. 1400 crores, (approximately US$233 million), showing an annual growth of 16%. The sale accounts for 82% of the topical dermatology market, a clear reflection of the popularity of topical steroids. There are a total of 1066 brands of topical steroids sold in the Indian market. The top selling combination preparations of topical steroids contain beclomethasone, neomycin, and clotrimazole with a sale of Rs. 152 crores (approximately US$25 million**) in 2013. This is followed by combination products containing clobetasol, ofloxacin, ornidazole, and terbinafine, with sales crossing 110 crores (approximately $18 million**). Ineffective implementation of regulations or laws by regulatory authorities such as the Drug Controller General of India or state Food and Drug Administration and poorly developed pharmacovigilance practices in India has helped in the past to allow the manufacture and the sale of these FDCs, which continued to harm skin health. The Indian Association of Dermatologists and Venereologists and Leprologists (IADVL) has made several attempts to knock the doors of these regulatory authorities to stop irrational and unmonitored use of these FDCs with limited success. A special taskforce group, i.e. ITATSA (IADVL's taskforce against topical steroid abuse) was established. IADVL has also conducted various activities all over India to create awareness among general public about side effects of topical corticosteroids in majority of these FDCs. Although these FDCs are used by qualified dermatologists for a few selected indications (infected eczema or inflamed dermatophytosis) for a very short period of time not exceeding 2–3 weeks, it has been emphasized by ITATSA that its use beyond the designated time and for other indications by unqualified health professionals should be discouraged. With the present Gazette notification by the Government of India prohibiting the sale and manufacture of harmful FDCs, efforts of IADVL's ITATSA and other health associations in India are bearing the fruits!
ITATSA's current fight against unsupervised and misuse of another FDC consisting of mometasone or fluocinolone, hydroquinone, and tretinoin is continuing and many foot soldiers are still battling for the cause. Though this FDC is not featuring in the list of prohibited FDCs, due to safety concerns, this FDC is used by a dermatologist for the treatment of melasma for a short period of time not exceeding 4–6 weeks. However, its self and unmonitored use in India has created more side effects than effects. The problem has worsened when pharmaceutical/cosmeceutical companies have started running advertisements of corticosteroid-containing creams (e.g., NOSCAR ® cream, UB-Fair ®, etc.) in the print and electronic media and promoting them as fairness creams. These creams are purchased and used by the patients without any doctor's prescription as Schedule H provided exemption for topical or external use preparations from the purview of Schedule H and H1 in the note appended to these schedules. To prevent over-the-counter sale of topical preparations containing steroids and antibiotics, it was proposed by IADVL to amend the note which states, “the salts, esters, derivatives, and preparations containing the above substances excluding those intended for topical or external use (except preparations containing steroids) are also covered by this schedule.” The government has considered the proposal to amend abolishing a footnote in the country's rule book on medicines that currently exempts skin creams from being labeled as Schedule H drugs. It is expected that regulatory agencies such as DGCI will take proactive step to disallow such practices when certain pharmaceutical companies are misleading general public to promote sales.
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