Pharma weekly wrap: FDC ban and Shivinder Singh's U-turn hog the limelight

This was an action-packed week for the pharmaceutical and healthcare sectors with the ban on fixed drug combinations (FDCs), fresh developments in the Singh brothers' saga and Sun Pharmaceutical Industries' US Food and Drug Administration approval.

FDC ban

This week saw the government banning 329 Fixed Drug Combinations (FDCs). FDC is a cocktail of two or more drug ingredients.

The government took the decision after the sub-committee headed by Nilima Kshirsagar under the Drug Technical Advisory Board (DTAB) gave its recommendation supporting the ban.

The government ban mostly covered drug cocktails for treating cold and cough, antibiotics, painkillers, anti-depressants, diabetic drugs, among others. The sales of these drugs accounted for 0.8 percent, or around Rs 1,040 crore, of the total sales in Indian Pharmaceutical Market in the year ended August 2018, according to pharmaceutical market research firm AIOCD.

Another 15 FDCs largely cold and cough brands have managed to escape the ban, as they were approved before 1988. These are said to be worth over Rs 750 crore including brands such as Abbott's Phensedyl Cough Linctus, Griffon's Grilinctus, Cipla’s Cofdex, Nocold and Bromolin, Glenmark’s Ascoril C, Intas' Despol and Reckitt Benckiser's D-Cold Total.

FDCs in India is a controversial subject. While WHO recommends just 25 FDCs for treating specific diseases like HIV, hepatitis-C, malaria and tuberculosis, in India, there is a combination for almost every drug. Most of them exist to bypass the drug price controls imposed by the government.

Singh brothers' saga

There is no end in sight for Singh brothers' saga. Just a week after Shivinder Singh filed a petition in National Company Law Tribunal (NCLT) against his elder brother Malvinder Singh and for Religare executive Sunil Godhwani, alleging 'oppression and mismanagement' of RHC Holding, Religare Enterprises and Fortis Healthcare, he withdrew the case citing respect for their mother.

Shivinder went on to make serious allegations against brothers like misappropriation of funds, forgery and pushing the group into a debt trap.

Shivinder said that he wants to settle the case amicably with his brother, but the split will stand.

But Shivinder's complaint was damaging for the brothers as Religare Enterprises moved NCLT against brothers to recover siphoned funds.

The brothers have lost management control over Fortis and Religare and are facing heat from Japanese drug maker Daichii Sankyo, which is trying to enforce a Rs 3,500-crore arbitration award it got from a tribunal in Singapore. Last month, Fortis shareholders' approved a sale of their company to Malaysia’s IHH Healthcare for $1.1 billion.

Sun Pharma gets US nod to Xelpros

India's largest drug maker Sun Pharma announced that it got an approval from USFDA for its specialty opthalmic drug Xelpros, which is used to treat chronic eye disease glaucoma.

Interestingly, the New Drug Application (NDA) of Xelpros was filed from the Halol site in Gujarat. The approval from Halol site is significant as it comes after the recent noise surrounding the observations received by the facility. USFDA had withheld approvals from this facility for four years due to a warning letter but cleared the facility early this year.

Sun Pharma management earlier indicated that the peak sales guidance of Xeplros is expected to be in the range of $50-$75 million over two to three years.

Indian Pharmaceutical Market grew 8.7 percent in August

The Indian pharmaceutical market (IPM) grew at 8.7 percent in August, much slower than in July due to lacklustre sales of anti-infective drugs, according to market research firm AIOCD-AWACS.

In July, the industry grew at the fastest past of 12.7 percent.

IPM grew close to 10 percent in first five months of this financial year FY19, returning to the 10 percent growth of FY17. In FY18, the growth dropped to 6.1 percent in the run-up to GST and its subsequent implementation.

The IPM reported sales of Rs 11,342 crore for August.