OVER 16 months after the secretary, Department of Health Research (DHR), Soumya Swaminathan, wrote to the Drug Controller General of India (DCGI) and senior health ministry officials with a request to ban 37 drugs that she termed “very harmful”, these drugs continue to be freely available in the market. The DCGI had acted on Swaminathan’s email, which was sent on November 12, 2015, seven days later with a suggestion to the health ministry that a committee should be formed to look into this “complex” matter. But the ministry, in response to an RTI filed by The Indian Express, has stated that no such panel had been formed till January 27, 2017.
The 37 fixed-dose combinations (FDCs) listed by Swaminathan in her email are commonly used antibiotics. For example, one drug listed by Swaminathan is Cefpodoxime + Clavulanate, which is used to treat diseases like pharyngitis, urinary tract infection, gonorrhea and pneumonia.
When contacted, Swaminathan, who is also the director-general of Indian Council of Medical Research (ICMR), told The Indian Express: “The DCGI has to take further action. ICMR can only bring to their notice. In fact, they had taken action on many FDCs but much more is needed on irrational combinations. The pharma companies should cooperate.”
According to IMS Health, a global market research company, this drug is sold by more than 70 companies — including Sun Pharma, Pfizer, Wockhardt, Mankind Pharma, Alkem Laboratories, Lupin, Zydus Cadila, Glenmark Pharma, Cipla and Dr Reddy’s Laboratories — in India under different brand names.
In her 2015 email, Swaminathan had stated: ‘’I am attaching a list of irrational antibiotic combinations that need to be banned. The list has been prepared by a group of ID physicians from the Clinical Infectious Disease Society of India (CIDSCON). I agree with them that these are very harmful and will spur additional antibiotic resistance in the community. I hope some action can be taken by DCGI. Am happy to assist in any way possible.’’
This email was sent to B P Sharma, the then health secretary; G N Singh, DCGI, who heads the Central Drugs Standard Control Organization (CDSCO); K L Sharma, joint secretary, health ministry; Jagdish Prasad, director-general of Health Services (DGHS) and S Venkatesh, director, National Centre for Disease Control (NCDC). None of these officials responded to queries sent by The Indian Express seeking comment.
The present health secretary C K Mishra also did not respond to queries sent by The Indian Express. Sun Pharma, Glenmark Pharma and Cipla said they are not aware of Swaminathan’s email and therefore can’t comment on it.
A Pfizer spokesperson told The Indian Express: “We currently market two out of these combinations listed by you and have not been informed of any concerns on either of these. We place utmost emphasis on patient safety and will continue to remain committed to ensuring the safety and quality of our medicines.”
Wockhardt, Mankind Pharma, Alkem Laboratories, Lupin, Zydus Cadila and Dr Reddy’s Laboratories did not respond to requests by The Indian Express seeking comment.
On November 19, 2015, G N Singh, DCGI, wrote a note to the health ministry, stating: “Considering the complexity involved in the issue, examination of each of the antibiotic combinations included in the list forwarded by secretary (DHR) needs to be examined separately considering all aspects of safety, efficacy and present status.”
Singh proposed that a committee of experts under the chairmanship of Swaminathan, comprising experts from institutes like All India Institute of Medical Sciences (AIIMS), New Delhi, “may be constituted for detailed examination and recommendations”.
Singh stated that the proposed committee’s recommendations will enable top health ministry body Drug Technical Advisory Board (DTAB) “to take final decisions through deliberation”.
On January 27, 2017, the health ministry told The Indian Express — in response to an application filed under Right to Information (RTI) Act, 2005 — that no such committee “has been constituted so far by this ministry to examine 37 antibiotic combinations”.
The ministry stated that “three irrational antibiotic combinations (Cefixime + Azithromycin, Ofloxacin + Ornidazole Suspension, and Metronidazole + Norfloxacin) out of 37 mentioned in e-mail of Dr Soumya Swaminathan were banned by the Government vide notifications dated 10.3.2016. However, the Delhi High Court has struck down the said notifications.”
These three drugs were part of the 344 FDCs that were banned on March 10, 2016, by the central government on the recommendation of committee formed under the chairmanship of Professor C K Kokate. This 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. Antibiotic resistance is the ability of a microorganism, which is causing the disease, to withstand the effects of an antibiotic medicine.
On December 1, 2016, Delhi High Court struck down the ban stating that the government had acted in a “haphazard manner”. This January, The Indian Express had also asked the health ministry if there was any committee or any other government department that is currently examining the issue of banning 37 drugs mentioned in Swaminathan’s email. The ministry replied that it has “no such information”.
CIDSCON and Indian Drug Manufacturers Association (IDMA) did not reply to the queries sent by The Indian Express.
The Organisation of Pharmaceutical Producers of India (OPPI) declined to answer queries on behalf of member-companies. D G Shah, secretary-general, Indian Pharmaceutical Alliance (IPA), told The Indian Express: “We are not aware of any communication from the government specific to these 37 FDCs. Some general notices have been put on the website of the Central Drugs Standard Control Organization (CDSCO) and the ministry of health & family welfare about the FDCs from time to time.”
Swaminathan’s email stated that these 37 specific drugs “will spur additional antibiotic resistance in the community”.
On February 1 this year, the DCGI wrote a letter to associations of doctors and pharmacists on the subject of “rational use of antibiotics for limiting antimicrobial resistance”.
The DCGI stated in the letter: “Antibiotic resistance is the result of environmental and behavioural causes. Indiscriminate prescription of antibiotics and laxity of enforcement laws are the main causes of antimicrobial resistance. This may be due to injudicious use of antibiotics in hospitals as well as in private practice apart from easy availability of prescription drugs in the country. In this regard, it is requested that you may kindly sensitise your members by raising awareness for rational use of antibiotics so as to curb antimicrobial resistance in the interest of patient safety.”