 "M&As peak in pharma industry; So does regulatory glare")
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 $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.
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 $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 $880 million (over Rs 5,610 crore) to take control of US-based Gavis. Drug major Sun Pharma also inked deal of over $48 million to acquire US-based eye-care firm InSite.
Another homegrown pharma major Cipla also paid $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 $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 per cent 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
Globally also, it remained a year marked with record mergers, led by the $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.
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The biggest of the deal came from Pfizer which stitched a $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 $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 $880 million (over Rs 5,610 crore) to take control of US-based Gavis. Drug major Sun Pharma also inked deal of over $48 million to acquire US-based eye-care firm InSite.
Another homegrown pharma major Cipla also paid $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 $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 per cent 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