Reacting strongly against the ban on 344 FDC drugs, industry veterans call it a hasty decision and question the government’s approval process which had earlier given the nod to these drugs. Edited excerpts of their insights By Usha Sharma
‘FDC ban will be bad for immediate financial health of any company’
There is substantial loss to companies as order prohibiting Fixed Dose Combination (FDC) was sudden. The industry has not been given any time and prohibition is with immediate effect. Companies have to stop production forthwith and it is expected that the packing material lying with them needs to be destroyed. The raw materials may be used in other formulations, the packing materials cannot.
Government’s move in banning FDCs
The issue to prohibit FDCs may be going on for the past 10 years. The new drug department was occupied more for assessing ‘new chemical entities’ and probably did not have enough resources to see that all FDCs need a closer look from patient safety angle. Few of the state licensing authorities were referring cases to them for clearance. It has appointed new drug approval committee (NDAC) and later expert committee. It did not have the machinery to see that all FDCs are first approved by the DCG(I) and then granted permission to manufacture.
Secondly, the government did not have any power to exercise control over the state licensing authority.
Alternative to FDCs
Physicians have to look for safer substitutes. Their source of information has to be very good. It may be easy in bigger cities, however, will be difficult in smaller cities and towns. A particular company’s price-to-sales ratio (PSR) who was promoting his FDC may not be in a position to inform about the safer alternative. Therefore for sometime when the patients will shift from FDC to single drug, they may suffer. Physicians need to be constantly consulted even for long-use products e.g. such products where physician prescribes for six months or even more. Patients who visit nursing homes or hospitals may face more difficulties. This may be beneficial when FDCs with some synergistic effects will only be available and rest are weeded out.
Impact on ‘Make in India’ initiative
The ‘Make in India’ initiative is to reduce dependency on anything that we are importing. FDC ban will definitely be bad for immediate financial health of any company. It may withdraw the zeal of a company to contribute to PM’s ‘Make in India’ initiative.
Alternative ways for growth
Companies, having strong R&D base, may go for technology improvement and increase acceptance of their brand. Simple products through nano-technology are appearing in the market now. I again emphasise different strategies for long-use and short-use products. Antibiotics are short-use products and I feel the FDCs may be marketed only when good synergistic action is demonstrated. Personally, I feel antibiotics need not be presented in FDCs except those where dose compliance has been demonstrated to be far superior to single antibiotics.
Road-map
The discouragement of FDCs without scientific rationale is going to be there for some time with the Central Drugs Standard Control Organisation (CDSCO). Industry associations must emphasise to regulators that patient’s safety is equally their concern as well as that of regulatory bodies. Combination products need to be formulated with sound justification of each ingredient. Combinations are very useful for geriatric, illiterates and other patients for better medication compliance. Industry must address this aspect and approach the regulatory bodies. I am sure regulators will understand this. Industry has to be there for fulfilling patient’s need and unwarranted curbs. Sudden notification gives the impression that genuine manufacturers have little concern for patient and are only profiteering.
– Kapil Bhargava, Former Dy Drugs Controller
‘The DCG(I) has no business to ban FDCs which are in the market for more than 30 years’
The recent ban on FDCs by the office of DCG(I) is a knee-jerk reaction to the recent observations by international agencies on the relatively poor regulatory standards of the CDSCO and DCG(I).
With the increasing global trends of TBT/ NTB being built up and targeted towards India’s pharma exports, the Government of India (PMO, DIPP etc) has of late been pressuring the Ministry of Health and Family Welfare (MoHFW) and the CDSCO to join ICH and PICs at least as an observer. Fully realising the internal weaknesses of the system and the CDSCO, the MoHFW and DCG(I) has apparently deflected the external pressures on to the pharma industry, through this ‘irrational blanket and abrupt ban.’
It is admitted that India is weak on pharmacovigilance. Why so? Both IMA, DCG(I)-CDSCO, DoP and others are to blame. In the 70’s, all formulations used to be packed into cartons with product inserts indicating mode of use, indications, contra indications, warnings etc. With the increasing NGO influence, making ‘hue and cry’ about “Indian drug prices being highest in the world”, the NPPA started cutting drug prices to below practical levels, forcing the industry to abandon all ‘frills’ in packaging thereby throwing to the wind, all product information through leaflets, which would have helped in pharmacovigilance.
Phenacetin, Analgin, Diiodohydroxyquin, Iodochlorohydroxyquin, Cox-inhibitors such as valdecoxib and Rofecoxib, Propoxyphene and Dextro propoxyphene, Methaquolone were all single ingredient drugs which were in market for three to four decades before getting banned based on pharmacovigilance data i.e. evidence-based. Some of the 344 drugs which are now banned unilaterally and abruptly are not only having no reports of side effects or adverse drug reactions, but also these very same combination drugs have become synonyms for lifesaving and well-being.
Patient misery
I strongly feel that some of the drug combinations bed abruptly will hurt patients badly. I am surprised why the DCG(I) has not thought of this priority concern
The sad part of the story is that the regulator has totally ignored the misery to the patient all of a sudden, denying access to a drug they were relying on for years.
The DCG(I) has no business or powers to ban FDCs which are in use in the market place for more than 30 years or thereabout. The ban is ultra vires, devoid of natural justice and merits to be struck down. While fully agreeing that there are true black sheeps and genuinely ‘irrational’ combinations, DCG(I) needs to ask each of the pharma companies who own and market the 344 banned drugs to explain why they should not be banned. Having killed the ‘clinical trial’ and pharma BA/BE study facilities, through poor and passive response to Supreme Court (under pressure from NGOs), DCG(I) cannot and should not ask each of these brand owners to conduct fresh clinical trials and submit data for approval in new format. The historical data of use, benefit and lack of risk is good enough data to approve or formalise the approval.
If a high court judge in a patent injunction case, considers patient’s interest for access to treatment, the DCG(I), being custodian of patient health, on behalf of MoHFW, ought to have thought of the patients who were availing these combination drugs for years. If one looks at past history of ‘bans,’ they have all been through phasing out and not abrupt bans.
Actions against unapproved drugs
It is unfair to say that there are “many unapproved drugs in the Indian market.” Being in the pharma industry for nearly 50 years, I can safely vouch that if there are any “unapproved drugs” in the Indian market, it has to be spurious or illegal. Any person or company marketing or selling ‘unapproved’ drugs merit to be summarily put behind bars. All drugs legally sold in the Indian market are approved by one or other ‘licensing authority’. The dispute is due to the concurrent nature of Drugs & Cosmetics Act, which grants the power to approve both to the State FDAs as well as to Central CDSCO/DCG(I) in case (only) for ‘new drugs.’ ‘New drugs’ are defined in the Drugs Act, as those which are introduced for first time in Indian market. A ‘New Drugs’ ceases to be new drug after four years. If an ‘approved drug’ (whether by State FDA or CDSCO) is in the Indian market for more than four years (leave alone 40 years), it cannot be banned abruptly. The DCG(I) should give individual companies the opportunity to be heard, justify the combination, make changes if needed as per suggestion/advise of DCG(I)/ State FDA and seek ‘minimum’ additional evidence, if required. The actual market place data is many times more valuable, reliable and evidence-based than any data generated through volunteers.
Need of intense focus
The Indian pharma industry is being attacked on multiple fronts both openly as well as surreptitiously. Various treaties, agreements, non-tariff barriers, technical barriers etc. are being put up to stem the growth of Indian pharma. While the PMO, DIPP and Commerce Ministry is aware of this, the officers at the grass root level are becoming victims of NGOs and vested interests, both from within the country as well as overseas to dilute the gains made by Indian pharma industry post-1970 and mostly post-1995 (WTO-TRIPs).
The FDC ban will badly impact PM’s ‘Make in India’ initiative. It will also malign Indian pharma’s name in the global markets. This will also stem the otherwise strong potential of Indian pharma to be world leader in combination drugs and therapies.
The roadmap from here onwards for the Indian pharma industry is to unite in national interests, insist for industry representation in all technical, legal and statutory committees. Indian industry must take note (too late) of “JNU- Kanhaiya” type NGO activity, which is well-entrenched in the corridors of Delhi, the presence of which need to be alerted at the highest levels. These negative activities which are well planned to damage the fair name and contributions of Indian pharma industry, need to be countered unitedly by Indian pharma industry, at the same time identifying and weeding out the wrong doers within, if any.
– Dr Gopakumar G Nair, Chief Executive Officer, Gopakumar Nair Associates
‘FDC ban and the US FDA alerts are a wake up call for the industry’
The Indian pharma industry which has earned the distinction of being the ‘Pharmacy of the World’ is currently facing strong headwinds impacting its growth and profitability. Rigid price controls, weak IPR enforcement, US FDA alerts, intense competition from cheap API imports from China, reducing tax incentives for R&D etc. have taken its toll. As if this is not enough, CDSCO has now banned 344 FDCs with immediate effect many of which have been in the market for over two decades and some even approved by the DCG(I). Apparently some more are likely to be added to this ban, resulting in about ` 3500-crore loss in sales. This is also likely to slow down M&A activity many companies were pursuing for inorganic growth. While the Delhi High Court has given an interim stay on the ban, resolving issues through litigation has always been painful and time consuming process. While financial loss is only secondary to patient safety, in a science based industry like pharma, key decisions like this have to be taken based on scientific principles and laid down processes rather than knee jerk reaction as shown by the CDSCO. As regards the timing of the ban which came in to force one day prior to the PIL filed by the former Ranbaxy whistle blower Dr Dinesh Th