The Drugs and Cosmetics Act 1940 (Act) is a Central Act to be implemented by all the States. The Act along with the other associated Acts and the rules made thereunder regulate the import, manufacture, distribution, sale and clinical research of drugs and cosmetics. In Gujarat, huge shortage of Drug Inspectors adversely affected the functioning of the Drugs and Cosmetics Act and the menace of spurious drugs continued to prevail. No follow-up action was taken to withdraw the drugs declared as not of standard quality from the market. The licensing system was ineffective and the DCA did not maintain proper record. Monitoring at State level was poor. Thus the objective of prevention of the menace of spurious drugs to eliminate the danger to human life had not been achieved. Following are the main audit findings:

1. Inadequate strength of technical staff weakened the enforcement of the Administration and diluted regulatory functions.
2. There was sharp increase in pendency in the cases of prosecution.
3. Sales of drugs without complying with the conditions of licences were noticed. 105 sales licences were issued to pharmacies without registered pharmacists to supervise sales in contravention of the provisions of the Act. Shortfall in inspections ranging from 54 to 69 per cent (manufacturing units) and from 63 to 77 per cent (selling units) was noticed. Two Blood banks with serious deficiencies collected 5948 units of blood. Real magnitude of spurious/Not of Standard Quality drugs sold in the market could not be assessed due to inadequate sampling. Under-utilisation of capacity of the laboratory resulted in delay in testing and follow up action. Inordinate delay in despatch of the drug samples to the testing laboratory resulted in delayed declaration of NSQ drugs. Delayed declaration of NSQ drugs resulted in selling of NSQ drugs before they could be withdrawn.
4. Sub-standard drugs worth Rs.68 lakh purchased by CMSO and ESIS were not replaced.