Drug industry, Pfizer lead in health lobbying

WASHINGTON — The drug industry's trade group and one of the nation's biggest pharmaceutical companies reported spending more money than other health care organizations on lobbying in the second quarter of this year.

With the fight over President Barack Obama's effort to revamp the nation's health care system escalating, the Pharmaceutical Research and Manufacturers of America said it spent $6.2 million lobbying in April, May and June, according to reports to Congress due Monday. Pfizer Inc., the New York-based producer of numerous drugs, ranked second in the health care sector at $5.6 million.

In reports filed by 11 p.m. Monday, 22 health-related associations and companies had reported spending at least $1 million each lobbying during the quarter.

The stakes are huge for the health industry. Congressional Democrats are pushing legislation that could cost roughly $1 trillion over the coming decade, paid for in part by cuts in federal health care programs such as Medicare. Lobbyists have been flooding Capitol Hill for months, and many interest groups have already invested millions of dollars in ad campaigns favoring or opposing various portions of the emerging bills.

According to the nonpartisan Center for Responsive Politics, the health sector reported spending $127 million in lobbying during the first three months of this year, more than any other area.

It can take many days for all the reports to be filed. In the second quarter of 2008, 28 health care concerns reported spending at least $1 million lobbying.

Of the thousands of reports filed by Monday evening covering lobbying on all subjects, only three organizations reported spending more during the second quarter than PhRMA, the drug industry trade group. The American Coalition for Clean Coal Electricity reported spending $11.3 million lobbying at a time when Congress is considering energy legislation. The U.S. Chamber of Commerce, the nation's largest business group, reported spending $7.4 million, and the General Electric Co. reported $7.2 million in lobbying expenditures.

Including its latest report, PhRMA has now spent $13.1 million lobbying so far this year. Pfizer has reported $11.7 million in lobbying expenses for 2009.

Other top lobbying spenders among health-related organizations for this year's second quarter included the American Medical Association, $4 million; Eli Lilly and Co., $3.6 million; the American Hospital Association, $3.5 million, and the Blue Cross and Blue Shield Association, $2.8 million.

Also, GlaxoSmithKline, $2.3 million; CVS Caremark Inc., $2 million; Bayer Corp. and America's Health Insurance Plans, representing the health insurance industry, $1.9 million each; Novartis and the Biotechnology Industry Organization, each $1.8 million, and Metlife Group Inc., $1.7 million.

Also, Sanofi-Aventis U.S. Inc. reported spending $1.6 million in the second quarter; Johnson & Johnson Services Inc. $1.6 million; Merck & Co. Inc. $1.5 million; F. Hoffman-La Roche Ltd. and its affiliates, $1.5 million; the American College of Radiology Association, Wellpoint Inc. and Astrazeneca Pharmaceuticals LP, each $1.2 million, and Siemens Corp. and UnitedHealth Group Inc., $1 million each.

Karnataka DC raids chemists, seizes huge stocks of substandard drugs made outside state

India, Karnataka drugs control department has seized drugs not-of-standard quality medicines sold at chemist outlets in the State. The drug test lab which conducted the analysis of the drugs has found that medicines were found non compliant with the analysis.

The drugs have been manufactured mostly by companies outside the state. These include companies from the excise free zone at Baddi in Himachal Pradesh.

The reasons for drugs not being of standard quality are inadequate quantum of active ingredients, non compliance with the requirement of sterility, disintegration, assay requirements, weight uniformity and presence of undesirable substances. Companies need to maintain the highest quality of manufacture and have to ensure re-checks at every stage to avoid getting into this situation, stated Dr BR Jagashetty, Karnataka drugs controller.

"We have alerted the pharmacy outlets, hospitals and nursing homes in the state not to sell or stock these drugs. The public have also been alerted to avoid purchase of these drugs which are available over-the-counter", he added.

United Biotech at Baddi has been engaged in the manufacture of Unifolin 50, Leucovorin Calcium injection. Goran Pharma located in the Gujarat Industrial Area was engaged in the production of Chlorhexidine mouth wash, Perix. Cooper Pharma in Delhi has been intimated for its enteric coated Aspirin. Enpala Laboratories located in the Industrial Area at Lokokere Road, Davengere in Karnataka manufactured Enpestine Expectorant which has been found lacking in the quality of contents.

Waksman Selman Pharmaceuticals Pvt. Ltd. has been producing Ciprofloxin in 250 mg strength which has been listed in the not-of-standard quality list. Oflocacin tablets sold under the brand name Ocinol was manufactured by Biotech Pvt. Ltd at Vadodara and Gentamic injection under brand name Lytamycin manufactured by Parenterals Pvt. Ltd. at Tetali, Andhra Pradesh are also in the list. Modern Laboratories which manufactures Cyanocobalamin injection (Vitamin 12) and Elmac Remedies (P) Ltd manufacturing Kufmac tablets also figure in the list of poor quality makers. All these drugs are being sold in outlets in the state.

The not-of-standard quality drugs are being produced largely by small scale manufacturers. These drugs are not found to be in compliance with IP/USP standards. The problem of discoloration and fungus infestations are serious issues associated with the drugs produced by the units across the country.

In yet another raid of some chemist outlets, the Special Court of Economic Offences has convicted the proprietor of Sri Ram Medicals for stocking the drugs marked as 'ESI Supply Not for Sale'. The accused has been convicted and will undergo simple imprisonment.

K'taka drugs dept seizes 4000 physician samples & low quality medicines

Swooping down on the violators of the Drugs and Cosmetics Act, the Karnataka drugs control department has seized around 4,000 physician samples from a pharmacy outlet in Shimoga district. Medicines worth Rs 3 lakh were also seized from an unlicensed premise at Gadag in north Karnataka.

The United Biotech located at Baddi has been engaged in the production of not-of- standard quality drugs and these have been seized in Karnataka. These drugs valued at Rs 9 lakh include Unifoli and Lucuverin injections.

Last month, the department had issued show cause notices for various violations detected at the manufacturing and sales premises. The enforcement officers carried out 1803 inspections on sales premises, 12 inspections on blood banks and 25 inspections on manufacturing units. It has suspended 87 sales licenses and cancelled 30 sales licenses. It has filed nine prosecution cases filed in the court. In the same period, eight cases were disposed of which five were convicted. Of the 16 cases received from the public are now being investigated.

In drug testing laboratory, a total of 319 samples were analyzed of which 22 samples were declared not-of-standard quality and investigations are being carried out.

Counterfeiting of pharmaceutical products and the proliferation of substandard drugs constitute a serious health risk for the public. There is a need to curb this practice and that is where the inspectors are on the constant vigilance drive, Dr BR Jagashetty, Karnataka drugs controller told.

The state has around 22,425 sales premises, 172 blood banks and 231 manufacturing unit. The drugs department with a view to bring about improvement in systems in order to tackle the malpractices conducts surprise inspections. Besides, it has also made it mandatory to manufacturers and pharmacy outlets to provide details of the products during assessments.

Further, the department also considers complaints from the public as a vital source of information. There is also a complaint handling process in place. The effort is to eradicate the unethical practices and bring about transparency. As the department is facing an acute shortage of manpower, the state government has sanctioned 370 posts, stated Dr. Jagashetty.

This increase in number of staff will help the drugs control department to continue its regular inspections which is the only way to deter malpractices. This can enhance the credibility of the manufacturers and the pharmacy outlets in the state, he added.