Delhi high court has already given a stay order on the ban of fixed dose combination drug when at least 14 pharma giants filed a petition against the notification. Many questions were raised from pharma side as well from different other section of healthcare industry –What is the rationale for banning the drugs that are doing good in the market for long? Who approved those formulations earlier? Is not it a hasty and overnight decision? Who are behind this ban? Finally, the man behind this ban speaks out. The ban of 344 fixed dose combination drugs by the government that shook the healthcare industry recently, is being highly questioned by drug makers. Companies have already earned an injunction and many are about to knock the door legislation. The question raised from Pharma sides are: Some of the banned formulations have a well-established efficacy and safety profile in India for more than 20-30 years and has both Central and State license and approvals. No show cause notice or hearing was granted prior to the notification. They were not informed, consulted or allowed a representation by the authority for defending their products. Their lawyer said that the government relied on “selective interpretation” of the Act and the process of consultations had not been followed. They alleged that the notification is silent on the aspect as to which expert committee was appointed by Health Ministry to examine the safety and deficiency of the fixed dose combination (FDC). An official from Indian Drug Manufacturers’ Association said companies should question that how can the combination products approved before the government’s 1988 safety cut-off and with the Central authority’s approvals be banned. An official from the Indian Pharmaceutical Association’s said that they were not against weeding out irrational combinations, but the process of law needed to be followed. The regulatory regime should be transparent and stable and should not be reactionary and knee-jerk. Rage of pharma sector is now moving from north India to southern part with the contemplation of South Indian Pharmaceutical Manufacturers Association (FOSIPMA) for a petition in the Madras High Court, seeking a complete stay order for all banned drugs. In the meantime, the head of the consultative committee that recommended the curbs on irrational combinations comes up with the explanation and justification of this whole act. He also headed the Pharmacy Council of India and was involved with the drug controller’s office to formulate guidelines for the use of FDCs. He is also acknowledged for his contributions to the field of pharmacognosy, a branch of knowledge concerned with medicinal drugs obtained from plants or other natural sources. He has also served as the vice chancellor of Nagarjuna University. He explained that: It is not an act of overnight whim, an expert committee combining top medical professionals with highest credentials worked for well over a year and had reviewed over 6,000 drug samples. They mentioned the drugs to be irrational and unsafe that are listed while most others were spared regulatory action. They have been completely fair in assessing the merits of the products and did not look at the brands of any drug or their companies. The committee’s mandate was to look at drugs which had received approval through state regulatory agencies. They reviewed the aspect of rationality, the merit of the formulations and the requirement of the formulation in treatment. He refuted the allegation from drug companies that they were not given a chance to defend and said that the companies had three months in their hand after a sub-clause notice was sent to them asking why their drugs should not be banned. They issued this notice completely for the best interest of the public. They exemplified that most of the enlisted drugs for banning consumed only by Indian patients and are not allowed in other countries. Some antibiotic combinations are so excessively used that they lead to resistance. It is being expected that another list with an almost similar number of drugs or more will be out soon the rattle the pharma industry with its after-shock. Some experts still think that sensible and mainstream pharma companies that have proven themselves as the long-term market leaders, will not be shattered by this ban but actually can leverage by boosting their mono-drug market. Sources: Times News Network, The Hindu Business Line Do you think this ban will boost both the prescription and manufacturing of single formula drugs, ensuring the patient safety and reviving the pharma industry as well?Combinations (rational or irrational) will be there as long as there is polypharmacy. Why blame the Pharma industry – they simply provide what doctors want. Patients want speedy relief with minimum medicines. Theoretically text book monotherapy is fine and works OK in NHS(UK) like system where patient are educated & have no scope of doctor hopping at will. Doctors can explain and take time to treat them. Here it is a market, where along with other ethical parameters – consumer satisfaction is also a paramount factor or else you loose your practice. So polypharmacy, so combinations. Rampant sale of any drug by the class 8 pass pharmacist in the shop without requiring any prescription does not bother anyone. Targets are only qualified and legitimate doctors and reputable Pharma companies. Irrational treatment will be there, as long as treatment is provided, in newspaper and magazines, on regional and national media TV broadcasts by any Tom, Dick And Harry without any restrictions. As long as health related product advertisements keep flooding the media and are allowed by the government – like Saridon, Zandu balm, Fair and Lovely (fairness in 4 weeks), Horlicks and the likes (taller, stronger,sharper), Chawanprash (silver gold etc), Zilaxo to name a few. God knows how many types of Ayurvedic, Yunani, Chandsi, Homeopathic medicines are made and consumed by millions in this country. I’m sure you can come up with thousands more products which are daily advertised and do a booming business. Products which have been causing innumerable side effects of which the specialists regularly come across Products about whose composition nobody knows nor cares. Why no list of them? Are they all very effective and rational? Why no action in those fields? Maybe Medial and pharma sector is easy to squeeze with additional benefit of being able to titillate public sentiment. And who in the first place gave approval and license for manufacture and sale of the products now being banned? The whole matter is far from rationality and transparency. The motive is in question.
multiple drug combination ban