M&As peak in pharma industry; so does regulatory glare

New Delhi: Facing an increasingly watchful eye of the health regulator in the US, Indian pharmaceutical firms are gearing up to tap new markets in 2016 as they look to consolidate their positions after a spate of mergers and acquisitions consummated this year.

Globally also, it remained a year marked with record mergers, led by the USD 160 billion deal between Viagra maker Pfizer Inc and Botox manufacturer Allergan.

These deals came at a time when the domestic pharma firms continued to remain under intense regulatory spotlight, specially of the US Food and Drug Authority (FDA), while they stared at yet another challenge domestically over possibility of prices of more drugs coming under government control.

The biggest of the deal came from Pfizer which stitched a USD 160 billion deal to take over Allergan. creating a global pharmaceutical behemoth.

It wasn't Pfizer's only deal -- the US giant also bought Hospira Inc, a leading provider of injectable drugs, infusion technologies and biosimilars, in a USD 17 billion deal.

Indian firms, including Sun Pharma, Cipla and Lupin, too took the acquisition path in their quest for international footprint expansion.

The biggest acquisition by an Indian firm in 2015 was by Lupin which agreed to pay USD 880 million (over Rs 5,610 crore) to take control of US-based Gavis. Drug major Sun Pharma also inked deal of over USD 48 million to acquire US-based eye-care firm InSite.

Another homegrown pharma major Cipla also paid USD 26 million (around Rs 166 crore) upfront to acquire majority stake in Uganda's Quality Chemicals.

Reflecting on implications of the events of 2015, Novartis India Vice Chairman and MD Ranjit Shahani, who was earlier the President of industry body OPPI, told PTI: "As pharma companies globally look at consolidating in some way or the other, Indian pharma firms would do well to negotiate the new pharma landscape. It will also provide them the opportunity to actually benefit from spin-offs."

Almost an year after announcing a USD 4 billion deal, Sun Pharma completed the merger of Ranbaxy with itself. The deal fortified Sun's position as the world's fifth largest specialty generic pharmaceutical firm and the top ranking Indian pharma company with significant lead in market share.

In contrast, Japanese drug maker Daiichi Sankyo sold its entire stake of around 9 percent in Sun Pharma for over Rs 20,420 crore, which it had received after merger of Ranbaxy with the Indian firm, ending its seven years of tumultuous experience in the country.

On the regulatory front, the year witnessed many Indian firms coming under the scanner of the regulator in the US, which remains a key market for Indian generic drugmakers.

Sun Pharma was forced to take remedial action at its Halol facility for lapses in manufacturing norms and was given a warning letter for the same. Earlier its another plant at Karkhadi, also in Gujarat, had received a warning letter from the USFDA after investigators found similar violations.

Hyderabad-based Dr Reddy's Laboratories also received a warning letter from the US drug regulator over quality issues at its two API manufacturing plants and a formulation unit in

Andhra Pradesh and Telangana. "Pharmaceutical companies will have to gear up to meet the increasingly watchful eye of the USFDA and this is bound to have an impact in the near term for companies who export heavily to the US," Shahani said.

Wockhardt had to recall 13 drugs in the US, manufactured at its two units at Chikalthana and Waluj in Maharashtra, which were under import restrictions from the USFDA.In the US, Cipla also recalled 1.41 lakh vials of Levalbuterol Inhalation solution used for relieving shortness of breath and coughing caused by asthma and chronic obstructive pulmonary disease for failed impurities and degradation specifications. Likewise, Mylan got a warning letter from the USFDA for violation of current good manufacturing practice (CGMP) norms at its three plants in Karnataka.

Drug maker Sharon Bio-medicine was issued a warning letter by the USFDA for failing to pay generic drug user fee by its owner for three years starting 2013, saying its

Dehradun-based facility would be barred from shipping products to the US if the dues are not cleared.

"Unless the major companies are successful in expeditious resolution of regulatory issues, the developed markets will continue to hurt the growth. The opening up of Japanese generic market and focus on the Latin America and Africa may bring some relief," Indian Pharmaceutical Alliance Secretary General D G Shah told PTI.

The year also saw the government making an attempt to expand drugs under price control by revising the National List of Essential Medicines which the industry felt would hamper growth of the sector.

Despite the odds, said Shah 2015 is expected to end with about 15 percent domestic market growth.

"The volume and value are consistent with the character of the generic industry...but new products growth is grossly below its potential. This is mainly due to slowdown in marketing approvals during the preceding two-year period and delay/denial of price approvals by the NPPA for new products during 2015," he said.

On expectations of the next year, Shah said 2016 is expected to maintain the current year's growth rate in the domestic market, against its potential of about 18 percent growth.

"This below potential growth is due to the change over to the NLEM 2015, which will enlarge the span of control adversely impacting value growth. It may in fact have negative impact. Besides, intense competition will lead to price erosion," he added.

The government, on its part, took steps such as measures to improve bulk drug manufacturing in India to reduce dependence on China; planning a separate ministry for pharmaceuticals sector to boost the domestic industry.

It also brought in the Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) effective till January 2016, for ethical marketing. A voluntary code as of date, the move was aimed at preventing pharmaceutical firms offering freebies and favours to doctors to get their drugs prescribed.

Besides, the government also announced plans to set up a Rs 500 crore fund for small and medium players in the pharma sector for upgradation of their manufacturing facilities to boost drug production in the country.

In the healthcare sector, Apollo Hospitals forayed into homecare services as part of new initiative by the company. Another healthcare provider Max Healthcare Institute inked agreements to acquire 76 percent stake in NCR-based Pushpanjali Crosslay Hospital for Rs 287 crore. Max was again in news when it said it will acquire 51 percent stake in Saket City Hospital here for an undisclosed amount from BK Modi group firm.

On the other hand during the year Fortis Healthcare in line with strategy to focus on the domestic market sold its Singapore hospital to Concord Medical Services (International) Pte Ltd for SGD 55 million (approx Rs 251 crore). During the year the company's Singapore arm completed 100 percent stake sale in RadLink for SGD 111 million (over Rs 530 crore) to Fullerton Healthcare Group.