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PROCESO DE MANUFACTURA EN LA INDIA

Manufacturing Process of Drugs in IndiaVarious departments and Ministry divisions oversee the regulation of the drug manufacturing process in Indian pharmaceutical facilities. With the rapid growth of the generic drug sector, contract manufacturing for export purposes has made India a global destination for affordable drugs. This has led to a drive to establish international standards, acquiring of certifications and adoption of Good Manufacturing Practices under Schedule M of the Drugs and Cosmetics Act. In addition to stepping up standards, volume and quality of generic drug manufacturing processes, there is also a shift towards increased R&D activity to devise new drug molecules.Manufacturing processes in the Indian pharmaceutical industry are regulated by the Central Drugs Standards Control Organization 1 under the guidance of the Ministry of Family Health and Welfare. A network of authorities work in tandem to ensure a plentiful production of quality medicines for the Indian as well as the global market.The Department of Chemicals and Petrochemicals directs policy planning, regulatory and development issues in the pharmaceutical sector in the context of industrial policy. The Pharmaceutical division of the department handles production, exports, imports, R&D, duty and pricing of drugs. The Export Promotion Cell gathers statistics on exports and imports of drugs and promotes growth of pharma exports. Matters of industrial policy including patent regulation, drug export and government support to the pharma sector are also handled by the Department of Industrial Policy and Promotion and the Director General of Foreign Trade, under the guidance of the Ministries of Commerce and Industry along with the Ministry of Chemicals and Fertilizers.Different ministries play a role in regulatory activities, depending on whether the product is a chemical, a biological drug or one based on recombinant DNA technology. Licensing and quality control concerns come under the aegis of the Department of Biotechnology, Ministry of Science and Technology and Ministry of Environment and Forests which co-ordinate market authorization with the Central Drug Controller. The Ministry of Health and Family Welfare scrutinizes affairs of the pharma sector with a focus on public health.

Contract Manufacturing, India is an attractive destination for contract manufacturing outsourced by multinational pharmaceutical companies. Contract manufacturing in India is projected to grow to US $3.2 billion by the year 2015, according to an estimate by the Organization of Pharmaceutical Producers of India. Indian pharma companies are highly established in the chemistry skills such as organic chemical synthesis and process engineering needed for manufacture of generic drugs. Thanks to this, the Indian pharma sector is able to manufacture drugs from all major therapeutic groups using complex manufacturing processes and Good Manufacturing Practices compliant facilities. The Indian drug industry excels in devising cost effective technologies to manufacture drugs at 40 percent cheaper that those in the Western world. This has made India one of the lowest-cost manufacturing nations in the world. Many Indian companies also enforce premier standards in stability, purity and International SHE (Safety, Health and Environmental) protection while producing and exporting bulk drugs. Indian companies develop superior Active Pharmaceutical Ingredients (APIs) than companies in other developing countries, without infringement of process patents. Large generic drug companies are outsourcing manufacture of off-patent molecules or contracting agreements with innovator companies to manufacture complex molecules that are under patent. A large number of Indian pharma businesses have sought and obtained international regulatory approvals for their manufacturing facilities from the USFDA (USA), TGA (Australia), Health Canada, MCC (South Africa) and MHRA (UK). In fact, India boasts of the biggest number of USFDA approved plants for manufacture of generic drugs. Many Indian companies have taken WHO GMP approval to enable exports to CIS countries and markets in Asia.

Good Manufacturing PracticesGMP or Good Manufacturing Practices are international guidelines to establish manufacture of quality drugs and medical devices. These practices were established by the WHO in 1975 to improve drug quality, safety, potency and efficacy. GMPs reduce the risks in manufacturing, testing, labeling, packaging, distributing and export and import of drugs, medical devices, cosmetics, blood and blood products. More than a 100 countries implement GMP, either as regulations (such as in Korea, United States and Japan), as directives (European Union) or as Codes (as in Australia).

Most of the bigger players in the Indian pharmaceutical sector are GMP compliant. And with the fast rate of growth of this sector, smaller companies are also adopting GMP to combat the menace of spurious drugs. The states of Karnataka, Gujarat, Andhra Pradesh and Maharashtra have accomplished a higher percentage of implementation of GMP, as compared with other states. On the global platform, the Indian pharma industry is also competing with other developing countries such as China.

Though implementation and follow up of GMP involves initial investment costs, the pay-off is in increased productivity and yield, improved staff morale due to better working conditions and a superior company image. Setting up GMP involves a cost-benefit ratio of investment versus returns, planning of product manufacture, a thorough understanding and implementation of the GMP guidelines, guidance from trained GMP experts and employment of experienced and qualified staff.

In India, Schedule M 2 of the Drugs and Cosmetics Act covers aspects of manufacturing of pharmaceutical products. These include:

* General requirements: Location of the premises, surrounding areas, water system, waste disposal
* Warehousing area
* Production areas
* Ancillary areas
* Quality control area
* Health, clothing and sanitation of Workers
* Personnel
* Manufacturing, operations and controls: Precautions against mix-up and cross-contamination
* Sanitation in the manufacturing premises
* Raw materials
* Equipment
* Documentation and records
* Labels and other printed material
* Quality assurance
* Self inspection and quality audit
* Quality control system
* Specifications: For raw materials, product containers and closures, in - process and bulk products, finished products, preparation of containers and closures
* Master formula records
* Packaging records
* Batch packaging records
* Batch processing records
* Standard operating procedures and records: Sampling, batch numbering, testing, records of analysis
* Reference samples
* Reprocessing and recoveries
* Distribution records
* Validation and process validation
* Product recalls
* Complaints and adverse reactions

Site master file: General information, personnel, premises, equipment, sanitation, production, quality control, loan license manufacture and licensee, distribution, complaints and products recall, self inspection, export of drugs

Indian drug companies are further strengthening their position in the world market by focusing on R&D in OTC formulations, phyto-medicines, high growth therapeutic segments and biopharmaceuticals. The swiftly changing trade, economic and intellectual property (IP) situation has resulted in the industry innovating and commercializing novel drugs through pioneering drug manufacturing processes.

1. Central Drugs Standard Control Organization2. Schedule M of Drugs and Cosmetics Act

Proceso
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