The government’s ban on manufacture and sale of 344 fixed dose combination (FDC) drugs may head towards the Supreme Court due to divergent views taken by high courts on staying the March 10 notification. While the Delhi High Court on March 14 stayed the ban, the Madras High Court refused to follow suit, saying “the mere fact of the sale of medicines for the last so many years ipso facto cannot call for the sale to continue when an expert body has gone into the issue. The larger public interest would weigh in favour of not staying the effect of the notification.”
The health ministry had banned these FDC drugs to ensure safety and efficacy of medicines. Most of these medicines are in the analgesics, antidepressant and anti-psychotics. These medicines also include FDCs based on codeine, used in popular cough syrups like Phensedyl and Corex.
The ministry said that FDCs are “irrational”, without any therapeutic efficacy, pose a “risk” to humans, and there are safer alternatives available. It added that the ban was imposed after thorough examination by a committee led by pharma expert Chandrakant Kokate. The panel had reviewed about 6,600 FDCs and classified them under four categories—irrational, require further deliberations, rational and require additional data generation.
However, the pharmaceutical industry says there is enough research to prove the efficiency of FDCs. The industry feels that banning a drug overnight would not only mean stopping production, but also taking back the products that are in the supply chain. Its estimates suggest the ban is likely to impact pharma sales to the tune of R1,500 crore.
The ban will adversely affect MNCs like Pfizer and Abbott and domestic companies including Alkem, Ipca Labs, MacLeods, Glenmark and Wockhardt. At present, there are more than 64,000 different formulations being manufactured and sold through pharmacies. Around 5,000 manufacturers, 8,000 brands, 75,000 wholesalers and 7 lakh drug retailers are affected. It will impact nearly 4% or R3,800 crore of the organised pharma retail market.
Advocate Dheeraj Nair of J Sagar Associates, who represents many pharma companies, says that the industry is pained to see the notification has been issued without giving them an opportunity “to represent their contention of how FDCs have justiciable therapeutic usage.”
“The government has so far not produced a single document controverting the same and has only been reiterating that it has power to ban under Sec 26(a). Historically, no such ban has ever been issued without giving an opportunity to stakeholders. And such power is used rarely and in emergent situations and not where the products have been in the market for decades,” the advocate added.
DG Shah, the Director General of Indian Pharmaceutical Alliance (IPA), is not opposed to the ban, but is against the procedure followed by the government. “The question is how the committee has identified 6,220 FDCs and what criteria was followed to ban 344 FDCs. No information with regard to both has been put in the public domain. No showcause notice was issued to get views from pharma companies,” he said.
Health experts, on the other hand, have welcomed the ban. They say that these drugs have done more harm than good, as some tend to be “spurious and non-effective.”
Dr SP Byotra, senior physician, Sir Ganga Ram Hospital, said that at times the symptoms don’t go despite medication, as the toxicity in many such combinations decreases the body resistance to fight any disease and even the low percentage of the effective ingredient doesn’t give much relief to a patient.
“Even FDCs have more side-effects than those of its individual components and sometimes the combination comes fraught with risks that are not there in the components,” the senior physician said, adding that such a ban can also curb unauthorised sale of drugs without a doctor’s prescription.
While the doctor admitted that some FDCs do have advantages like patients don’t have to take separate medicines with single components, and many a times FDC drugs are cheaper, he said that “the commercial interests of the industry can never be above public health and safety. The babus who cleared the drugs need to be taken to task for allowing such unapproved drugs.”
However, the ban is neither sudden nor irrational. According to the government, pharma companies were given ample opportunity by issuing showcause notices, but some didn’t even bother to respond.
A 2015 study by PLOS Medicine shows that of 175 FDC formulations across 4 categories in India, only 60, or 34%, were approved by the Central Drug Standard Control Organisation (CDSCO). The study also pointed that over 12% of non-steroidal anti-inflammatory FDCs contain drugs that have either been withdrawn from the market or have had their use restricted.
The Parliamentary Standing Committee on Health and Family Welfare, in its 59th report on the functioning of the Central Drugs and Standards Control Authority tabled in May 2012, had pointed out several loopholes in the approvals of FDCs, and that many of these already stood banned in western countries.
“Industry, the drug regulator and the expert committee need to work together to find an amicable solution without compromising patient safety and interest. The industry and the regulator cannot be in confrontation with each other in the court. Unfortunately, the developments in the last two weeks has done immense damage to all the three agencies globally. It is not the court but a dialogue which can resolve the stalemate,” Shah added.