At the same time, a Bain report states that although India continues to rise, it pales in comparison to China as a destination
of choice for low-cost drug manufacturing.
The overall facts, however, remain positive for India. Drug exports bring in more than $2 billion. There are 170 biotechnology
companies in India involved in the development and manufacture of genomic drugs. Sequencing genes and delivering genomic information
for Big Pharma is considered the next boom industry in India. And, Indian companies are getting more aggressive in expanding
their global footprint. Mumbai-based firms Nicholas Piramal, Sun Pharma, Glenmark, Wockhardt, and Cipla have deals that span
five continents—the surest signal of the growing global ambition of Indian pharma companies.
A. Nair is a freelance writer based in Mumbai, India.
Zone in on: Regulation
FDA Issues Rule to Clarify GMP Requirements for Aseptic Processing
by Patricia Van Arnum
The US Food and Drug Administration issued a rule on Dec. 4, that clarifies its requirements for current good manufacturing
practices (CGMPs) for aseptic processing, water standards, and verifications standards. Notice of the rule was published in
the Federal Register.
FDA issued the rule as part of a process for amending certain regulations in an incremental approach to modifying GMPs for
finished pharmaceuticals. These changes are designed to modernize or clarify some of the CGMP regulations and harmonize some
requirements with those of foreign regulators.
Among other changes, the rule deletes the current requirement for adherence to a specific US Environmental Protection Agency
water standard and instead simply requires that the plumbing system contain water that is "safe for human consumption."
The rule also amends several aseptic-processing regulations to clarify requirements and reflect currently accepted practices.
In some cases, the rule harmonizes the regulations with international regulatory standards. The revision to Sec. 211.113(b)
applies specifically to the validation of aseptic processes. Other recommendations concern various types of processes and
operations in addition to aseptic processes.
Comments are due 75 days after the publication of the rule, which will be effective 135 days after publication. If FDA does
not receive any significant comments during the comment period, the agency will publish a notice in the Federal Register 105 days after Dec. 4 to confirm the effective date of the rule.
India's Dr. Reddy's Laboratories signed an exclusive 10-year agreement with pharmaceutical company Sygnis Pharma (Heidelberg,
Germany) for the supply of the active ingredient in AX200, a biological molecule in development by Sygnis for treating stroke
and other neurodegenerative disorders. • Santen Pharmaceutical (Osaka, Japan) is using Oakwood Laboratories' (Cleveland, OH) "Chroniject" sustained-release delivery technology for its DE-102, a drug
to treat macular edema in Phase I–IIa clinical development. • Astral Pharmaceutical (Mumbai) formed an agreement with Sagent
Pharmaceuticals (Schamburg, IL) under which Astral will develop, manufacture, and supply injectable products for which Sagent
will obtain US regulatory approval and will market in the United States.
EUROPE &MIDDLE EAST
England's Hikma Pharmaceuticals acquired Jordan's Arab Pharmaceutical Manufacturing for $163.6 million. • Switzerland's Novartis
expanded its collaboration with MorphoSys (Martinsried–Planegg, Germany). Under a new 10-year agreement, which may be extended, the companies will discover and optimize antibodies in a wide range
of diseases. • England's Reckitt Benckiser agreed to acquire the specialty pharmaceutical company Adams Respiratory Therapeutics
(Chester, NJ) for $2.3 billion. Adams is currently active in the US only and markets two brands: "Mucinex," an adult cough
expectorant and "Delsym," a cough suppressant. • Switzerland's Roche may change the general language in its "Tamiflu" (oseltamivitor)
drug label based on a FDA recommendation to specify the potential for neuropsychiatric adverse events. • France's Rhodia Organics
will increase prices by 10–15% for its salicylic product range, effective this month.