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CALIDAD DE DROGAS MANOFACTURADAS:

Quality Control Policies for Drugs Manufactured in India Drugs manufactured in India account for over 10% of the world's total pharmaceutical output volume. A phenomenal growth in export of generic drugs has necessitated the strict monitoring of quality control by the Central Drugs Standard Control Organization. Strategies adopted include mapping regions in India where spurious drugs are peddled, a whistle-blower scheme for informers who alert authorities on counterfeit drugs, tightening up of industry standards and increasing the personnel monitoring drug quality. At the global level, the Indian government is active in calling for a resolution to the dispute between developing and developed countries on matters of intellectual property (IP) rights and public health anti-counterfeiting efforts. The Indian pharmaceuticals and drugs industry has been progressing immensely in infrastructure and technology base expansion, and product management. Indian-manufactured generic drugs are of high quality, in contrast to the common perception that generic drugs are of inferior quality because they are cheap. As Hans Hogerzeil of the World Health Organization says, “The quality of a product has nothing to do with the brand name.” India is one of the top 20 countries of the world exporting pharmaceutical products to over 200 countries, including well controlled markets in USA, West Europe, Japan and Australia. Globally, India is in 3rd position for generic production volume and in the 14th position for pharmaceutical exports value. The present size of the India pharma industry is Rs. 100,000 crores (US$ 20 billion), with over Rs. 39,000 crores being exported. It is expected to grow to US $40 billion by 2015, growing at 10-14% per annum, according to a recent statement by the Indian Minister of State for Chemicals and Fertilizers.

India has been a destination of cheap essential medicines including antiretroviral (ARV) medicines and recently anti swine flu drugs. Its Patents Act (1970) was amended only in 2005, in accordance with the World Trade Organization (WTO) and Trade Related Aspects of Intellectual Property (TRIPS) obligations. A crucial public health safety measure in this law restricts the granting of trivial patents such as those given to minor modifications of drug formulations. This is a common tactic used by drug companies to extend patents on medicines and a barrier to the availability of affordable medicines. Indian law ensures that patents are awarded to new and innovative medicines. The Pharmaceutical Policy framed in 2002 is a step up from the oft-modified Drug Policy, to enhance growth of the industry towards international quality. It has abolished industrial licensing for all bulk drugs cleared by the Drug Controller General (India), and also permits foreign direct investment up to 100 percent, except those produced by use of recombinant DNA technology, nucleic acids and specific cell or tissue culture formulations. It gives further impetus to R&D and has set up the National Institute of Pharmaceutical Education and Research. The Indian pharmaceutical sector has achieved self reliance in many areas, including a qualitative and quantitative increase in the area of research and development. This has led to India becoming a preferred choice for alliance and outsourcing for multinational pharma businesses. At least 10 top Indian pharma businesses have increased R&D expenditure by over 5% of their respective sales turnover, thanks to the fiscal incentives provided to them; this has accelerated their efforts in new drug innovation. Procedures in development of novel drugs, clinical research and drug delivery systems have been modernized. The Central Drugs Standards Control Organization (CDSCO) 1, headed by the Drugs Controller General of India, implements drugs' quality standards. It has some innovative schemes in place to check the quality, authenticity and efficacy of drugs manufactured in India. The geographical locations where spurious drugs are manufactured are identified and monitored by CDSCO in collaboration with the Indian Statistical Institute. Personnel are continuously trained in drugs standard control and conduct surveys nationwide to analyze drug samples. Testing facilities have been upgraded and new ones established, funded under the World Bank assisted Capacity Building Project. Central Drugs Laboratory (CDL) Kolkata is the appellate laboratory under the Drugs and Cosmetics Act; it carries out analytical quality control of drugs manufactured within the country as well as those sent to it by the Courts Schedule M of the Drugs and Cosmetics Rules (1945) regarding Good Manufacturing Practices makes it obligatory for drug manufacturers to comply with its requirements for quality control. State governments keep a close watch on traffic in spurious drugs, and maintain control over the quality of drugs manufactured in the country. A Whistle Blower scheme has also been set up by the CDSCO. Informers who provide information to designated authorities leading to capture of spurious, adulterated, misbranded or sub-standard quality drugs are rewarded by the Central Government. Drugs of sub-standard quality are categorized by the CDSCO as follows:

Category A: Spurious and Adulterated Drugs are medicines that are produced to resemble another drug, possibly a popular and widely-selling one. The active ingredients may or may not be present in the product.

Category B: Grossly sub-standard drugs that are made by licensed manufacturers but have major defects compromising drug quality. These defects may occur due to negligence or non-compliance with GMP.

Category C: Minor defects are those defects that arise because of minor variations in quality, due to insufficient pre-formulation development studies, inadequate controls in process by the manufacturer or unsuitable conditions of storage and transport.


In July 2009, the Drugs Controller-General of India (DCGI) added 170 drug inspectors to increase the total number to 200, in an effort to bring regulations in the pharma sector up to par with WTO guidelines.
From October 2009, the DCGI also assumed authority to issue:

WHO-mandated Certificate of Pharmaceutical Products (CoPP) intended to enable importing countries to obtain information about the safety, quality or efficacy of drugs they import from India.

WHO Certification Scheme for Good Manufacturing Practices (GMP) for medicinal products manufactured in India. This scheme was developed in response to the requests of WHO member states as a voluntary/non binding agreement to exchange information on the quality, safety and efficacy of imported drugs.


India is also actively involved in debates at the WTO, over disputes between the developed and developing countries over intellectual property rights and transshipment. Transshipment is a common legitimate tool used for economizing in global trade, by routing shipments through transit hubs. Recent seizures of Indian drug shipments as counterfeit were based on presumed violations of the transit country's patent law. This has fed public misconceptions that generic drugs from exporting developing countries, such as India and Brazil, are of poor quality. India maintains that the term 'counterfeiting' has different implications under IP law and drug regulation. The WHO defines counterfeit medicines to be 'deliberately and fraudulently mislabeled regarding identity and/or source'.

At present, the efforts by the Indian government have tightened up quality control standards in the India pharma sector. The challenge to Indian authorities is to prevent multinational drug companies and developed countries from promoting perceptions of a link between legitimate generic products and unsafe counterfeit drugs; this would undermine access to lawful, safe and low-cost generic drugs in developing country markets.

 

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