The problem with irrational drugs.

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Friends I will give you some interesting facts. Our drug market is about 60,000 crores. Of this around 40,000 to 50,000 crores is of "irrational" drugs. Drugs that are not recommended by any medical texts. Most drug combinations come under this category. 

No drug combination is recommended in any medical text but market entertains them for some practical reasons. Avoiding drug resistance and better compliance of medication are some objectives. 

India has over 6000 such combinations posing a great headache as there is no database maintained that could point out prescription habits, efficacy and adverse effects. The WHO 19th list of essential medicines contains 414 drugs of which 27 are combinations. The Indian essential list contains 376 drugs of which 24 are combinations.

After examining 1083 drugs 344 were approved for withdrawal but the final list was reduced to 328 (The Supreme Court has now reversed the ban on four drugs). If 50,000 crores (other reports indicate 110,000 crores) is the drug combination market, what will be the impact of the ban on 328 drugs? Only about 3000 crores. So still 47,000 crores remain a grey area. 

The doctors recommend the irrational drugs based upon the advice of seniors, medical representatives and the drug industry. However when cases are filed they are at a loss because they cannot substantiate their prescription with medical logic. This increases medico legal costs.

What are the problems with drug combinations? There are no strong studies to determine if two or more drugs mixed together retain their effectiveness. Also there are no strong studies to determine if they become more toxic. If your disease changes and there is need to change dose of one component, the doctor cannot do it because the drug is a combination the doctor cannot change. What it does to shelf life is uncertain. Thus the entire scenario is one of uncertain health risks. 

The solution will be to entirely move towards generics. No brand name but just chemical name. Only the approved combinations may be allowed with restricted scope for some more. That will reduce complications and will drastically reduce costs. 

Drug prices can be inflated up to more than 1000%. This entire money flows to the industry and other stakeholders. If the fee structure of doctors/ hospitals and services is fixed by a consumer committee and generics/ combinations made by government companies are popularised our health costs will become less than a tenth of what we spend today. 

However this also requires a dominant state owned public health role in both education and treatment. The other essential is moving towards integrated medicine. Health affecting factors in environment like pesticides, food additives, pollutants and unapproved chemicals need a strong hand of control. If people are encouraged and motivated to stay healthy and the system allows them to be so, the disease burden and health costs will reduce exponentially.

The Union Ministry of Health has banned the manufacture, sale or distribution of as many as 328 varieties of combination drugs in its efforts to keep a check on the irrational use of fixed dose combination (FDC) medicines. The move will likely affect over 6,000 medicine brands worth about Rs 25,000 crore across the country. The FDC medicines are two or more drugs contained in a single dosage form. They are manufactured to evade price control measures, and are low-cost drugs that can treat multiple diseases. The move was taken considering the larger public interest, says a government statement, adding that it will help curb the wrong use of 'unsafe' FDC medicines. Reports suggest the health ministry took the decision to ban these drugs after the Drugs Technical Advisor Board suggested these drugs might pose health risks.

With the ban, popular drugs like Saridon (painkiller), Gluconorm PG (used for diabetes), Lupidiclox (antibiotic), etc, will be no more in sale.
Experts believe combination drugs to be unsafe because unaware physicians can prescribe wrong dosage that can in turn make human body resistant to treatment. India's overall Rs 1.10-lakh crore drug market is saturated with over 25,000 brands. The government had initially brought in a notification to ban 345 combination drugs deemed 'unsafe' in 2010. Pharma companies and the government battled it out in various courts and eventually the Supreme Court directed the government to set up another committee to take a fresh look. Thereafter, the issue was examined by the Drugs Technical Adviser to study its overall impacts.
"It is a good move by the government to ban combination drugs. It has been seen that there was no rational use of FDC medicines. Previously, in March 2010, government had brought the notification to restrict about 344 categories of FDCs. However, it was challenged by various manufacturers in the court. In compliance with the directions given by the Supreme Court of India in its judgment dated December 15, 2017, the matter was examined by the Drugs Technical Advisory Board constituted under Section 5 of the Drugs and Cosmetics Act, 1940 and which furnished its report on these drugs to the central government," Delhi's Drug Controller Dr Atul Nasa told Mail Today.
Furnishing the report, the advisory board told the Ministry of Health there is "no therapeutic justification" for ingredients contained in these 328 FDC drugs. It has also pointed out about risks involved with these drugs with regards to human health. After considering the recommendations of the advisory panel, the government decided to ban these 328 FDC drugs in the larger public interest.

Year : 2016  |  Volume : 48  |  Issue : 4  |  Page : 347-349
Fixed dose drug combinations: Issues and challenges in India

Department of Pharmacology, All Institute of Medical Sciences, New Delhi, India;year=2016;volume=48;issue=4;spage=347;epage=349;aulast=Gupta