Exporting drugs to different countries depends on the regulatory system of the both the courtiers. Import and export of drugs from a pharmaceutical industry are allowed after gaining all the approvals.
Earlier in India, the export of drug was not a cumbersome process but, now the Indian regulatory system is too fragile. It takes about a year or so for a drug to be approved for marketing. The ever-changing laws, regulations, and demand have completely tossed the approval process. The Central Drugs Standard Control Organisation of India controls the import and export of pharmaceutical products.
Drug registration Process
Drug registration is a system meant for all the pharmaceutical products. It is required for pre-marketing evaluation, marketing authorization, and post-marketing review so as to ensure that all the products fall in the standards of quality, safety, and efficiency. In short, drug registration is the issuance or denial of a license for the marketing and promotion of the pharmaceutical product. The drug registration process involves a number of steps. The pharmaceutical industry at first has to send an application of assessment.
After receiving the application is rejected or issued for assessment which suggests acceptance of the application. After this, the drug registration process starts. In it, the first step is the Assessment of Applications for New Marketing Authorizations. The assessment is done on quality, manufacturer’s GMP profile, product information/labeling, interchangeability, efficacy, safety, dispensing category, pricing etc. Although all these assessment procedures are not relevant for all the drugs, like safety and efficacy are used if any new chemical is being introduced, interchangeability is assessed only for generic products.
Next, the appointed staff on the assessed parameters makes a report. The assessment report prepared by the DRA consists of the brief outline of the information of pharmaceutical product and company; disagreement reasons if any with the applicant’s proposals; evaluation summary with details on interchangeability if applicable; and last the proposed final decision.
There are cases when the DRA feels that the information submitted is incomplete or wants additional information than it can send a letter. This is generally a request letter that asks about the additional information required on the product or explanation of any particular point.
Further, after getting all the required information DRA can issue marketing authorization or reject it. DRA also looks up that the proposed product information is considered in the export country or not. Once the application is issued and the drug is registered, DRA keeps a post follow up of all the marketing activities.
The follow up is based on quality checks; status of marketing; updating of the stable data; controlling the promotion activities; carrying out pharmacoepidemiologic studies to ensure its safety; and monitoring any adverse reaction of the product. In some cases WHO type certificate is also a prerequisite for gaining the approval for marketing or exporting to another country. Drug registration is thus a long cumbersome process as it is related to lives of many.