Spurious drugs problem are general, infrastructural and legal and measures are need to be tackled them at each level.
Spurious drugs are mainly the products which are deliberately and fraudulently mislabeled so as to conceal their identity and source of manufacture to cash-on the popularity of fast moving brands. It may or may not contain the active ingredients mentioned on the label. The circulation of spurious drugs is of great concern to everybody ie, the drug industry, regulators, medical profession and the general public.
- Very remunerative trade
- Large-scale sickness in small scale pharmaceutical industry
- Variation in size of industry and strength of regulators within states
- Too many retail and wholesale outlets
- Inadequate cooperation between stakeholders
- Availability of improved printing technology that helps counterfeiting
- Widespread corruption and conflict of interests
- Lack of control by importing/ exporting countries
Lack of adequate number of inspectors
- Lack of adequate laboratory and testing facilities
- Lack of facilities for speedy communication and mobility
- Lack of adequate funds
- Lack of adequate training in investigational skills
- Special courts for speedy trials – co-ordination with other law enforcing agencies – fear of law.
- Lack of – summoning powers to the inspectors
- Lack of enforcement of existing laws;
- Weak penal action
- Lack of uniformity in implementation
- Lack of uniformity of procedures adopted in licensing
- Creation of adequate infrastructure
- Bring restrictions in licensing of retail pharmacies to avoid agglomeration
- Limit the restricted licenses to rural areas
- Creation of Intelligent cum Legal wing in states and zonal office
- Identifying and notifying nodal officers in each state and zonal office for communications regarding spurious and counterfeit drugs
- Creating central registry for formulations under the brand names and their compositions
- Include under the conditions of manufacture that each manufacturer at periodical intervals have to carry out verification of supply chain and file returns with the FDAs
- Creation of advisory bodies at district level with NGOs and Consumer Associations
- Preparation of dossiers of suspected dealers and manufacturers
- Define exports and apply all the conditions applicable to local manufacturer for exports with proper exemptions in standards and labeling as per import requirements
All these efforts can only reduce the incidence of counterfeit and spurious drugs.