Improvement in drug manufacturing standards: an initiative of government of India

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Editorial, Mar 2015 issue

“ Globalization of the pharmaceutical industry has the potential to rapidly spread poor-quality medicines worldwide. This is due to lack of expertise, poor manufacturing practices. It influence public

Safety has been a prior concern for everyman. Today what ever we buy may it be a simple consumable item or a general medicine, we want to be cent % sure on its effectiveness and safety. Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. Endproduct testing by itself does not guarantee the quality of the product. It is necessary to build the quality into the product at every step and not just tested for at the end.

At the turn of the 20th century, there were no federal regulations to protect the public from dangerous drugs. Globalization of the pharmaceutical industry has the potential to rapidly spread poor-quality medicines worldwide. This is due to lack of expertise, poor manufacturing practices. It influences public health. They are an inevitable consequence of inadequate local regulation of the pharmaceutical industry and the lack of good manufacturing practices (GMP) facilities in many ‘developing’ countries. In Venezuela, for example, primaquine tablets were found to contain 19–168% primaquine, and one patient developed Plasmodium vivax malaria after taking primaquine containing 46% of the stated content. A significant proportion of sulphadoxine–pyrimethamine tablets available in Africa are substandard and fail dissolution testing because of incorrect formulation, resulting in poor oral bioavailability and reduced efficacy.

Poor quality medicine due to lack of manufacturing standards or any other factor strongly effect consumer. Any amount of poorquality medicine is unacceptable because it increases morbidity and mortality due to loss of medicine efficacy. There is always shown loss of confidence in health systems and health workers due to increased burden for health workers. As well as economic loss for patients, their families, health systems, and the producers and traders in good-quality medicines. Patients may also suffer adverse effects of unexpected ingredients, e.g. cotrimoxazole containing diazepam. This results waste of enormous human effort and financial outlay in development of medicines, optimising dosage, carrying out clinical trials, discussing policy change, and manufacturing medicines

Poor quality and product defects that lead to injuries and worse, death, as we've seen in the headlines this past year, will erode and even destroy a manufacturer's brand image in a way that can take years to rebuild. Consumers will stop purchasing if any medicine discovered to have once contained toxins. Such public flaws and brand erosion can be as costly as the demise of a company.

Drug Companies Fined
Periodically, the FDA fines a drug manufacturer when its abuses are impossible to cover up. In May 2002, The Washington Post reported that Schering-Plough Corp., the maker of Claritin, was to pay a $500 million dollar fine to the FDA for quality-control problems at four of its factories. The indictment came after the Public Citizen Health Research Group, led by Dr. Sidney Wolfe, called for a criminal investigation of Schering-Plough, charging that the company distributed albuterol asthma inhalers even though it knew the units were missing the active ingredient. The FDA tabulated infractions involving 125 products, or 90% of the drugs made by Schering-Plough since 1998. Besides paying the fine, the company was forced to halt the manufacture of 73 drugs or suffer another $175 million fine. Schering-Plough's news releases told another story, assuring consumers that they should still feel confident in the company's products. This large settlement served as a warning to the drug industry. According to The Washington Post article, a federal appeals court ruled in 1999 that the FDA could seize the profits of companies that violate "good manufacturing practices."

Since that time, Abbott Laboratories has paid a $100 million fine for failing to meet quality standards in the production of medical test kits, while Wyeth Laboratories paid $30 million in 2000 to settle accusations of poor manufacturing practices.

Now only those drugs are preferred by consumers which provide a high level assurance that medicines are manufactured in a way that ensures their safety, efficacy and quality. Medicines are manufactured to comply with their marketing authorization. The government is introducing the Drugs and Cosmetics (Amendment) Bill to amend the existing Act to consolidate provisions for clinical trials and regulate medical devices for improvement in drug manufacturing standards, Central Drugs Standard Control Organisation takes initiatives for 2015 includes the introduction of the Bill. The initiatives include revision of good manufacturing practices (GMPs) for drugs as well as medical devices under the Drugs and Cosmetics Rules, 1945, to modify the requirements to ensure their safety, efficacy and quality. As well as the initiative include introduction of provisions relating to phytopharmaceutical drugs. It will also include simplification and rationalisation of various formats of applications and licenses under the Drugs and Cosmetics Rules, 1945.[1]

Bhavik Narsana, partner, Khaitan & Co, a legal consultant, said, "It would be a welcome move to amend the Drugs and Cosmetic Rules. The whole process will invite public discussion and debate, and also prompt meaningful legislative changes. Changes to GMP standards could possibly be in response to the criticism of Indian manufacturing units' compliance standards. One would expect a greater level of harmonization between Indian and global standards."[1]

1. › Money Tuesday, 6 January 2015 - 7:00am IST | Place: Mumbai | Agency: dna “Government seeks to raise pharma manufacturing standards to global level”

- Shalini Sharma