Globally pharmaceutical products are manufactured, but locally may not available in every country. Therefore, some percentage of pharmaceutical products have to import from the manufacturing country. This generates pharmaceutical products trading across the globe.
Pre-formatted regulation is essential for the ethical and business-oriented trading of pharmaceutical products. Organizations like the World Health Organization (WHO), the World Trade Organization (WTO), and the International Trade Organization (ITO) are taking responsibility to regulate the pharma business. Besides these organizations, every country has its own rules and regulations. A country like India has occupied the third position in the world in the field of Pharmaceutical industry.
The Ministry of Health & Family Welfare and the Ministry of Chemical & Fertilizers regulate the pharmaceutical and chemical industries. India is still facing discrepancies in the Research and Development of pharmaceutical products due to economical as well as other circumstantial issues. Multinational companies are taking the pharmaceutical market in India to overcome inconsistencies. This trend encourages the in and out of pharmaceutical products in this country.
The European Union, North America, and Asian countries mainly import pharmaceutical products in India. India has an “EXIM” policy to Import and Export pharmaceutical products under the special policy.
However, this policy also encourages both quantitative and qualitative improvements in the field of R & D activities. In different parts of India have 11 Port offices, which are working under the Central Drugs Standard Control Organization (CDSCO) to import and export of pharmaceutical products in a regulated manner.
World health organization(WHO) has issued regulatory guidelines to import Pharmaceutical products on the basis of these following conditions:
· Public health considerations insist that Pharmaceutical products (mainly medicines) should not be used in a similar fashion as in ordinary commodities. Both national and international manufacturing and subsequent handling of Pharmaceutical products must follow the prescribed standards and thoroughly controlled within the distribution chain. This precautionary measure ensures that the patients receive standard quality Pharmaceutical products, and prevents the permeation of sub-substandard and/or suspected illegitimate supply of Pharmaceutical products.
· Sometimes the limited availability of pharmaceutical products occurs due to financial limitation, a complication in following production norms and standards, and resource deficiency in their supply chain. The availability of substandard and suspected illegitimate Pharmaceutical products creates a risk to public health. Enforcement of stringent rules and regulations at the customs level is crucial to make sure that the patients are getting high-quality pharmaceutical products.
· For continuous improvement in border control can be possible through establishing a worldwide standard economical scale and scope. This can be possible by a pro-active approach to controlling the reactive system to analyze the risk associated with traditional trading. Organize a risk-based surveillance scheme to identify the risk and subsequently describe the control measures for patient protection from substandard, illegitimate, and unregulated Pharmaceutical products supply. This risk-based approach can improve the cost-benefit ratio with existing or compact resources through more useful and competent controls.
· Thirty-ninth World Health Assembly (WHA) conducted in 1986, adopted revised medicines strategy. The World Health Organization (WHO) built Guiding principles for small national drug regulatory authorities for establishing a regulatory approach to assure both the quality and the safety and efficacy of the distribution of pharmaceutical products under a protection guideline.
· An official contract requires between participating Member States become a compulsion to emphasize the requirement for the effective use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. This is necessary to obtain export permission for any pharmaceutical product from marketing authorization in the country of origin where the product manufacturing conforms with WHO guidelines on good manufacturing practices for pharmaceutical products.
· Assurance of imported pharmaceutical products must have the relevant marketing authorization that they remain secure within the distribution chain is essential for ensuring that shipment of imported products is in compliance with all particulars require within administrative and other safeguards scheme. Storage and transportation facilities must give protection against corrupting and undesirable conditions, and pertinent controls must be applied at every stage of shipping.
· Pharmaceutical products that fall under narcotic drugs and psychotropic substances must be controlled under international conventions to follow the rigorous border control to prevent the diversion and illegal exchange of products during transportation.
Following documentation for each consignment is required to provide the customs authority by the importing agency or agent for prerequisite customs clearance
· The national regulatory authorities must issue certified documents in the importing country. This document must be attesting that the importer is dully authoritative by license authorized to undertake the contract.
· The pharmaceutical product is duly certified by licensing authority to be marketed in the importing country or else sanctioned for clinical trial use or for named patient use.
· Manufacturer needs to issue a batch certificate fulfilling the requirements under the WHO Certification Scheme. The final quality control analytical documents of the batch(es) comprise the consignment and safety data sheet.
· An authorized, germane invoice or bill and, its validity is required to release the pharmaceutical product for foreign exchange. The required documentation must be issued by the competent national authority in the country of import. Along with these, any other documentation necessitates by national legislation for customs clearance must be taken care of before shipment of the pharmaceutical products.