The Union health ministry needs to revisit its decision to ban fixed dose combination drugs (FDCs) comprising antibiotic combination therapies which have long been found to be effective against drug resistant infections, says noted patent expert, Dr Gopakumar G Nair.

India had experimented on antibiotic combinations over the years. One of the early antibiotic combinations was Streptopenicillin, of the sixties which was very effective for throat infections, but has since been banned as declared irrational. Many Indian pharma companies introduced oral formulations/dosage forms with 2 to 3 antibiotics with or without Lactobacillus. In antibiotic resistant and persistent upper respiratory tract and lung infections, these combinations had been showing extraordinary beneficial results, Dr Nair said.

As early as 2001, Cipla, a pioneer in anti-retroviral therapy, introduced the word’s first ever 3 in 1 FDC to fight AIDS. Combivir, Trizivir and many combinations and kits followed by globally with astonishing synergistic results.

But, the ban on FDCs including antibiotic combination therapy, which were in market for several years, appears to succeed in destroying the advantage and the lead that India had established over developed countries, who could very well have been beneficiary of the steam rolling against FDCs in India, he opined.

According to the noted patent expert, antibiotic combination therapy has been found to be effective against drug resistant infections in recent research.

As per researchers presenting UCLA Research paper, the three drug combinations can have really beneficial results which is supporting much higher than those ever predicted from all pairs of antibiotics. As per the report “different classes of antibiotics use different mechanisms to fight bacteria. One class, which includes amoxicillin, kill bacteria by preventing them from making cell walls. Another disrupts their tightly coiled DNA. A third inhibits their ability to make proteins. But there had been little previous research indicating that combinations of three antibiotics might be more potent together than any two of them”. The research paper was published in the proceedings of the National Academy of Sciences.

Having been associated with the Indian pharma industry for nearly 50 years, the current ‘FDC’ controversy has erupted abruptly causing serious problems for the Indian pharma industry, at a time when the Indian pharma is already reeling under the international non-tariff barrier pressures and hurdles.

Regulatory systems such as FDA, CDSCO, DCG(I) are equipped to safeguard the interests of the consumer by providing for quality efficacious medicines for the patients. When more than one drug is combined rationally, this can lead to synergy, in which case, if novel, can lead to patentability. Even if not novel, inventive and devoid of synergy and hence not patentable, the combination drugs can lead to patient benefit by avoiding to have to take multiple drugs in independent doses. The expertise and experience gained by India on combination therapy is being deeply impacted negatively by this ban of FDCs. Need for existing FDCs in the market to freshly conduct clinical studies, at a time when the clinical trial options systems and infrastructure itself is similarly dented and disturbed, is further complicating and negatively being impacted, he added.

In spite of severe NGO pressures domestically the Indian pharma has been surviving from export-sales and profits. With pressures of US FDA inspections in the new formats, the NTBs such as PICs and TPPs like treaties from overseas markets, the Indian regulatory agencies and their lead ministries need to review the rationale behind multi-pronged attack on the Indian pharma industry, among which the “FDC Ban” is the latest “bolt from the blue”.

As such, a more positive approach to the fixed dose combinations in India (past, present and future) need to be adopted by the health ministry of India, as well as whosoever is pushing this negative initiative intensively, he concluded.