Pharmacy News: India Contract Manufacturing Industry Set for Magnificent Growth
India Contract Manufacturing Industry Set for Magnificent Growth
India has become a prominent destination for the purpose of contract manufacturing of pharma products due to rising concerns over high production costs. Additionally, pharma giants are looking for convenient and faster transportation of products to the target markets. Besides, sponsor companies are looking to outsource related services, such as product development, packaging, and logistics. According to our latest research offering, “Indian Contract Manufacturing – A Hot Opportunity”, the contract manufacturing industry in is expected to grow at a magnificent CAGR of over 45% during 2011-2013. Growth will be much higher than the past years as the impacts of the global recession are wearing off from the market.
Contract manufacturing will also help the pharmaceutical companies to meet with the growing demand for new drugs and improve their core competencies. The report depicts the overall market scenario across the prominent destinations in the developed and developing regions of the country. Apart from the current market scenario in these destinations, the report covers the initiatives, which are being taken up by the State Governments. The report also includes detail competitive analysis of key players functioning in the Indian contract manufacturing industry. A prudent analysis of the trends and drivers of the market delineates the favorable avenues for the purpose of contract manufacturing.
Our report “Indian Contract Manufacturing – A Hot Opportunity” also covers various issues being faced by the contract manufacturing industry, including IP issues, investment risks, and issues related to quality assurance. These segments are aimed to provide a pragmatic outlook of the contract manufacturing market, thereby allowing the identification of shortcomings of certain avenues in the industry.
Analysis of the ongoing developments, market expectations, and driving factors facilitates clear outlook of every aspect of the industry. Besides current market scenario, forecasting in the report provides a clear picture of the industry’s future scenario. The report would help clients in enhancing their understanding regarding the industry and thereby, formulating strategies to help their business grow.
Budget 2011: Pharma firms want tax cuts, R&D sops boost
MUMBAI: Drugmakers want tax exemption deadline for export oriented unit (EOUs) to be extended and want infrastructure or priority sector status in the budget on Feb 28.
The deadline for full exemption of tax on net profit for export oriented units, or EOUs, ends in March, though drug-making facilities in special economic zones would not be affected.
The exemption beyond March 2011 will provide relief to companies like Dishman Pharmaceuticals and Chemicals, Divi’s Laboratoriess , Cipla and Torrent Pharmaceuticals , which run EOUs.
The government may grant infrastructure or priority sector status to healthcare, which would help draw more investments and lower costs, N.R Munjal, president, Indian Drug Manufacturers’ Association, told Reuters.
“The output of R&D is still considered as an intangible asset and hence, banks or financial institutions are not ready to support R&D projects. The government should either make certain norms for funding or set up a venture capital fund,” he said.
Pharma companies, with annual sales of over 1 trillion rupees including exports of 450 billion rupees, spend 4-7 percent of their revenue on R&D against 12 percent by their Japanese counterparts and more than 14 percent by the Chinese.
The last budget had raised weighted deduction on in-house R&D expenses to 200 percent and the industry hopes it would be extended to cover outsourced projects such as clinical trials and specific lab studies, including those incurred overseas, brokerage Sharekhan said in a note.
The move will incentivise investment in R&D and encourage new drug development , it said, adding it would prove positive for Biocon and Piramal Life Sciences , both major outsourced R&D segment players.
“We expect government to have an equal excise duty for APIs and formulations as this will help the smaller players who primarily depend on APIs,” Kamlesh Udani, executive director, JB Chemicals and Pharmaceuticals, told Reuters.
The duty on active pharmaceutical ingredients (APIs) is 10 percent while its 4 percent for formulations or finished dosages. “An equal duty structure for both APIs and formulations would help draw parity between the big and small players in the industry,” said Sushant Dalmia, analyst with Pinc Research.
Pharmaceutical reps are salesmen, court rules
The employees of drug manufacturers who try to persuade doctors to prescribe their products are salesmen, even though they don’t actually sell anything, the 9th U.S. Circuit Court of Appeals has ruled.
In a decision with industry-wide implications, the federal judges rejected arguments by two former Arizona employees of SmithKline Beecham Co. that they cannot be classified as “outside salesmen.” That distinction is critical because such workers are not entitled to overtime.
Judge Milan Smith Jr., writing for the unanimous court, acknowledged that the U.S. Labor Department filed a “friend of the court” brief supporting the position of the two former workers – and, by extension, of everyone else still working for the company known as GlaxoSmithKline, and potentially for the entire industry.
But Smith said the court owes no deference to the agency’s position. “And, in any event, we respectfully disagree with that interpretation,” he said.
Central to the question is what constitutes sales.
Federal law precludes drug companies from selling their products directly to the public. Instead, individuals can get these items only through a prescription from a physician.
The sales staff, officially called “pharmaceutical sales representatives,” call on physicians to educate them about the company products and urge them to prescribe them over the items sold by competitors.
According to the former salesmen, they visited up to 10 doctors a day. They also worked 10 to 20 hours a week outside normal business hours studying Glaxo products, preparing sales materials, checking e-mails, answering phone calls and attending events.
Federal law precludes these pharmaceutical sales reps from selling the samples they have, taking orders from physicians or negotiating drug prices with either doctors or patients.
Pay includes a base salary and an incentive, the latter based on things like whether Glaxo’s market share for a particular product increases in the pharmaceutical sales representative’s territory, sales revenues increase, or the dose volume increases. The company said it aims to have salary at 75 percent of compensation with 25 percent for incentives, though there is no cap to that incentive.
Federal labor regulations define an “outside salesman” as someone who makes sales or obtains orders, and who is primarily away from the company’s offices. Based on their duties, and federal restrictions, the salesmen said they do not fit that definition.
Smith disagreed.
“Plaintiffs’ contention that they do not ‘sell’ to doctors ignores the structure and realities of the heavily regulated pharmaceutical industry,” the judge wrote. With patients unable to purchase drugs, Smith said the “sale” in this case is a non-binding commitment by a doctor, at the end of a sales call, to prescribe more of the drug.
“Through such commitments, the manufacturer will provide an effective product and the doctor will appropriately prescribe,” Smith said. “For all practical purposes, this is a sale.”
Smith also said that the reps’ primary duty is not to educate doctors or even to promote Glaxo products in general. He said these are “but preliminary steps” to getting a doctor to prescribe more of a specific drug being pushed by the salesman.
And Smith noted that without this commitment – and without the sales that follow – the pharmaceutical sales reps would not receive a commission.
Maccine partners on preclinical imaging lab in Singapore
Contract research organisation (CRO) Maccine will set up a preclinical imaging laboratory in partnership with the Singapore Bioimaging Consortium (SBIC) under a deal announced late last week.
The ‘Translational Imaging Industrial Lab’ (TIIL) will provide imaging services for small and large animals with tech ranging from micro positron emission tomography to computed tomography and dual emission X-ray Absorptiometry (DEXA).
The unit will also offer bespoke imaging protocol development services that can be tailored to the pharmaceutical firm’s specific project needs.
The ability to develop imaging protocol’s is somewhat lacking in the wider CRO sector according to Maccine, which claimed that at present only four or five companies worldwide offer this type of service for preclinical development.
Maccine’s partnership with the SBIC, which is part of the Government Agency for Science, Technology and Research (A*STAR), follows just months after the Singaporean CRO opened a non-human primate (NHP) imaging centre in the country.
Now, as then, Maccine cited the pharmaceutical industry’s desire to increase the efficiency of research spending and reduce attrition rates in mid to late stage clinical trials as the key motivation for the investment.
CEO Leigh Berryman said the lab “Will allow early establishment of imaging methodologies in the drug development process [which] presents the exciting possibility of projecting the efficiencies offered by this technology straight into the clinic.”
This was echoed by SBIC executive director Philip Kuchel who said: “Imaging now occupies a vital place in the industrial drug development process but it is a constantly evolving field.
“This tie-up will allow the latest R&D advances achieved through the laboratories of SBIC to be applied directly to practical questions in drug discovery and development”