FDCs on their way out?

October 15, 2018 0 By CH Unnikrishnan

The recent ban of 328 Fixed Dose Combinations (FDC) drugs with immediate effect by the Union Health Ministry  is set to cost roughly Rs 2500 crore to the pharmaceutical industry in India. The ban is likely to hit 40-60 pharmaceutical companies and around 6000 brands, according to the industry experts.

The health ministry banned manufacture, sale and distribution of 328 FDC drugs after an expert panel, which was set up by the Drugs Technical Advisory Board (DTAB) to study safety, efficacy and therapeutic justification of the drugs, recommended that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings.  The list of banned FDCs include many popular drugs. Meanwhile, the ministry has restricted manufacturing, sale and distribution of six other FDCs drugs subject to certain conditions. FDCs are drugs
in combinations of two or more
active ingredients in a fixed ratio in a single dosage.

“The industry will see an erosion of about Rs 2500 crores following the ban of the FDC drugs.  There are certain companies who have majority of these products and they will be affected badly,” said Daara B. Patel, Secretary General, Indian Drug Manufacturers’ Association (IDMA). However, he added that it won’t have much impact on the pharmaceutical industry in India, which has a size of over Rs 1 lakh crore.

FDCs unsafe

Welcoming the ban, All India Drug Action Network (AIDAN), an independent network of several non government organizations working to increase access and improve the rational use of essential medicine, said in a statement that none of the FDCs meet the criteria of a rational and safe FDC. The people of India have been made the consumers of unsafe medicines for too long and this is one step towards rectifying the grave situation of a pharma market brimming with innumerable irrational FDCs.

“It reinforces our constant demand for approval, and use, of only rational medicines in India. Rationality needs to be demonstrated by safety, efficacy and therapeutic justification. None of the FDCs meet the criteria of a rational and safe FDC. The people of India have been made the consumers of unsafe medicines for too long and this is one step towards rectifying the grave situation of a pharma market brimming with innumerable irrational FDCs,” said AIDAN.

Under section 26 A of the Drugs and Cosmetics Act 1940, the Health Ministry had banned the manufacture, sale and distribution of 344 FDCs for human use in March 2016. Later five more FDCs were added to the list. The health ministry banned these FDCs after an expert committee headed by Prof CK Kokate declared them unsafe. However, many affected manufactures contested the ban in Supreme Court and various high courts. The ministry moved the apex court challenging a Delhi high court order that quashed the ban. AIDAN had also filed a petition in the top court against the Delhi high court order.

In December 2017, the Supreme Court had asked DTAB, the country’s top drug advisory body to review manufacture and sale of FDCs. Subsequent  to the apex court direction, an expert panel was formed under the chairmanship of Dr. Nilima Kshirsagar, Professor, Head, Clinical Pharmacology, G. S. Medical College, KEM Hospital, to review safety, efficacy and therapeutic justification of the FDCs. The panel recommended ban of these drugs citing safety issues and lack of therapeutic justification. The board in its report concluded that there was no therapeutic justification for the ingredients in 328 FDCs and that these FDCs may involve risk to human beings. It recommended banning the manufacture, sale or distribution of the FDCs in larger public interest. But 15 out of 344 FDCs in the original list, which were claimed to be manufactured prior to September 1988, were excluded from the current as the Supreme Court had stated that the government cannot ban the 15 FDCs on the basis of DTAB report.

Tip of iceberg?

“When the ban on FDCs was notified, pharma companies in court cases questioned the locus standi and powers of the Central government to ban drugs in India. That issue has been settled decisively with the recommendations of the sub-committee led by Dr. Kshirsagar” said AIDAN in its statement.

AIDAN has also urged the government to take swift action on the 15 FDCs that were excluded from the notification on the basis of safety and efficacy considerations. “We note however, that the FDCs under scrutiny account for approximately Rs. 2,500 crore in sales and represent only the tip of the iceberg. In our estimation, the market of unsafe, problematic FDCs in India is at least one fourth of the total pharma market valued at Rs. 1.3 trillion,” it said.

Meanwhile, another round of legal tussle is expected to ensue in the coming days with many companies approaching courts against the ban. The Supreme Court allowed sale of Saridon, Dart, a pain killer and Piriton Expectorant, which is used for common cold, cough and other conditions, in September. The apex court’s interim order came on petitions filed by GlaxoSmithKline, Piramal Healthcare and Juggat Pharma. While Saridon is manufactured by Piramal Healthcare, Piriton is owned by GlaxoSmithKline and Dart by Juggat. The court in its interim order permitted the companies to manufacture and sell the drugs until final judgement is passed. Challenging the ban, the companies reportedly claimed that the only reason given in the notification was that FDCs had no therapeutic value. In another development, Indian pharma major Wockhardt approached Delhi High Court against the ban as its anti-inflammatory drug Ace Proxyvon. According to industry sources, more companies are expected to approach courts in future against the ban.

Clinicians say that before banning the combinations, drug authorities should ensure that the individual
drugs are available in the market. Otherwise, it could lead to the shortage of some crucial medications. “There were occasions where the ban of a particular combination drug, for example, the drugs containing codeine, was banned leading to severe shortage of this important medication,’’says Dr Vinod B Nair, an otolaryngologist from Kochi, adding that “so long as it is
not going to affect the availability of
the crucial medications the ban
wouldn’t make much impact in day to day practice.”

Box story

High Court allows drug makers to sell existing stock of FDCs

The Delhi High Court has allowed the sale and distribution of already manufactured stock of the 328 fixed-dose combination (FDC) drugs banned by the government on September 7.

Offering an interim relief to ten pharmaceutical companies, the Court directed the firms to file an affidavit with the court indicating the ‘batches already manufactured’ by them as a measure to ensure the quality of the drugs.

The Court further ordered that no coercive action would be initiated against the manufactures, stockists as well as dealers of the banned FDC drugs, as per the court directive which allows the sale of FDC drugs for the time being. The High Court, however, directed the companies to stop all manufacturing operations with regard to the banned FDC drugs.