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CERTIFICACIÓN DE DROGAS

Certifications of Drug Manufacturers of IndiaSummaryIndia has attained global leadership in the manufacture of generic drugs following the modified drug patent law, which came into effect in 1970. This law permitted Indian drug manufacturers to reproduce branded drugs through novel methodologies without running the risk of patent violations. Since then, Indian drug companies have shown immense progress in reverse engineering techniques.Globalization has enabled India to become the largest and cheapest producer of major drugs for critical ailments such as AIDS. Drugs manufactured in India have come to be the lifeline for developing nations in Asia and Africa, and an essential alternative to expensive treatments in developed countries such as the US and in Europe.Primarily driven by the objective to provide indigenous and affordable health care amenities to its large population, the Indian government implemented amendments to the existing Patent Act in 1970. The amendment provided patent protection only to drug manufacturing processes and not the products themselves. This move curbed the expensive monopoly of international drug manufacturers in the Indian market by permitting domestic manufacturers to reverse engineer branded drugs through novel methods of synthesis. The stipulation was that the generic drug should exhibit bioequivalence to the branded drug. This critical development was a shot in the arm for the Indian pharmaceutical industry, which proceeded to flood the market with reliable generic drugs for various maladies such as heart disease, diabetes and AIDS. The Indian population benefitted from affordable allopathic treatment for most common ailments. With the advent of globalization and development in infrastructure, India started to export generic drugs to markets overseas and has, since the last few years, emerged as one of the major generic (allopathic) drug producers of the world. In developing nations such as the African countries, affordable generic drugs made in India provide relief to patients of AIDS or cholera. Indian drugs are also an affordable alternative to expensive medical treatments in developed nations such as the US, where the population is in need of readily available solutions for chronic ailments such as diabetes and cancer. India's ability to successfully fulfill the varied demands of both the developing and developed worlds stems from three main factors:

* Highly educated and technically sound work force
* Sizable local population with high demand for treatment for almost all kinds of ailments
* Availability of energy and other raw material inputs at low costs


India sells indigenous generic drugs, APIs (Active Pharmaceutical Ingredients), intermediates and injectables to other developing countries as well as developed nations at more affordable prices compared to the western pharmaceutical innovators. Continuous progress in the pharmaceutical sector, bolstered by industry-friendly patent laws, supported the growth of various domestic drug manufacturers. For instance, one Indian pharmaceutical company is currently the world's largest manufacturer of antiretroviral drugs (ARVs to combat HIV/AIDS) and provides affordable treatment for the AIDS-infected population in African and Asian countries. The exponential growth of generic drugs manufacturing in India called for more stringent monitoring in order to ensure compliance with the certification processes of developed nations. Moreover, the global pharmaceutical industry also witnessed several changes. Perhaps, the most important of these is the introduction of the intellectual property law in the global trading system in 1995. TRIPS (The Agreement on Trade Related Aspects of Intellectual Property Rights) ruled in favor of the manufacturers' rights to patent their drugs, and applies to all the members of the World Trade Organization (WTO). Since the implementation of TRIPS was to have a huge impact on generic drug production, the majority of developing nations including India were granted a ten-year transition period in which to ensure compliance. India and other developing nations were permitted to continue development of generic drugs until 2005. Least developed countries have until 2016 to effect compliance. Several international bodies certify drug-manufacturing units based on audits and tests of conditions followed by the manufacturer.(1) Good Manufacturing Practices (GMP)a) WHO-GMP This is applicable to developing nations. In India, the Central Drugs Standard Control Organization (CDSCO), part of the Indian Ministry of Health & Family Welfare, undertakes inspection of manufacturing units and awards the WHO-GMP certification. Functions such as licensing of drug manufacturing, sales establishments, and drug testing laboratories are executed by the respective State Drugs Controllers. The Indian government is contemplating a centralized modus operandi for issuance of WHO-GMP certificates to drug-manufacturing units. b) Current GMP (cGMP)This is enforced by the US FDA or the EU-GMP (the European Union's GMP). Compliance with cGMP standards requires further development in the infrastructure of drug-manufacturing units, which implies massive economic burden on small- and medium-scale enterprises (SMEs). In order to be able to market generic drugs in the US, it is essential for manufacturing units to comply with cGMP regulations. With its advanced technical knowhow and constant developments in the field, India has the largest number of generic drug-manufacturing plants approved by the US FDA outside the US. (2) International Organization for Standardization (ISO)

ISO is a non-government organization. It collaborates with the WHO for harmonization of regulations and public policies. ISO does not audit or assess the management systems of organizations. Auditing and certification of management systems is undertaken independent of ISO by more than 2,500 certification bodies active worldwide.(3) Other International Drug Regulatory Bodies

Indian pharmaceutical companies have secured international regulatory approvals for their plants from many other globally recognized agencies such as MHRA (UK), EMEA (European Union), TGA (Australia), MCC (South Africa), and Health Canada. Over the years, India has established itself as a leading manufacturer and provider of generic drugs in the global market. India has been able to maintain the highest standards of purity, stability and International Safety, Health and Environmental (SHE) protection in the production and supply of generic drugs. Despite the implementation of TRIPS and other regulations pertaining to product and process patents, Indian pharmaceutical manufacturers are well poised to retain their global footprint. With immense support from the Indian government and extensive collaboration with academic institutions for research and development in the fields of chemistry, biochemistry, biotechnology and medical sciences, Indian pharmaceutical companies are making rapid progress in the innovation of new drugs.

Proceso
Nuestra Capacidad de organizar y gestionar los tramites y cumplir las normas internacionales para el mercado farmaceutico a nivel global es única, es por eso que somos su mejor opción en el mercado.