Drugs and Cosmetics Act

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Performance Audit on Implementation of Drugs and Cosmemtics Act in West Bengal (2012-2017)
(CAG of India, 11-07-2019) CAG of India
The Government of India (GoI) had enacted the Drugs & Cosmetics Act, 1940 followed by the Drugs & Cosmetics (D & C) Rules, 1945 to regulate manufacture, distribution and sale of drugs and cosmetics in the country. These were applicable to Allopathic, Homeopathic, Unani and Siddha drugs as well as other health related items. The Government of West Bengal established (1965) the Directorate of Drug Control (DDC) under the Health & Family Welfare (H&FW) Department for enforcement of the aforesaid Act and Rules. The DDC was mandated with licensing and inspections of manufacturing units, blood banks and sales premises, approval of formulations of drug for manufacture, drawal and testing of drugs samples for monitoring quality standards and initiating prosecution against offenders. A Performance Audit covering the period from 2012-13 to 2016-17 showed the following shortcomings: 1. The activities of drug control in the State were adversely affected by acute shortage in the cadre of Drug Inspectors as well as infrastructural and manpower shortcomings in the West Bengal State Drug Control and Research Laboratory (SDCRL). Inspections and sampling was meagre to effectively combat the sale of ‘Not of Standard Quality (NSQ)’/ spurious drugs. 2. Significant number of manufacturers/ sellers continued to be in the drug business without valid licences. 3. The test results of the Laboratory were doubtful as it often did not run all the mandatory tests on the samples. There was also delay in generation of test results by the laboratory by which time the NSQ drugs had been consumed by the patients. The Department was unable to create adequate deterrence against NSQ/ spurious drugs owing to inaction on cases reported to be NSQ and the inability to further the prosecution orders. Thus, consumers in the State remained exposed to serious health hazards from spurious and not of standard quality drugs.
Irregularities in Collection of Samples & Laboratory Analysis of Mediciens in Haryana
(CAG of India, 26-11-2019) CAG of India
A large number of licencees remained unchecked; sample analysis reports were issued late and where sample was found not of standard quality, action for recalling and issuing alert was initiated with inordinate delay. Destruction of substandard drugs was not monitored and subsequent batches were not checked. Risk of manufacturing, distribution and sale of substandard drugs was high with serious implications for health and even lives of general public.
Performance Audit on Drugs and Cosmetics Act in Gujarat (1997-2003)
(CAG of India, 2004) CAG of India
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.
Performance Audit of Implementation of Drugs and Cosmetics Act in Bihar (1998-2003)
(CAG of India, 2004) CAG of India
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. The Act was not implemented effectively in the State. The Drug Controller‘s office did not have master control registers indicating the numbers of manufacturing/ selling units, the validity period of licenses, the dates of inspections, dates of collection of samples, the reports of testing laboratory etc. Licenses to manufacturing and selling units were not renewed periodically. There was huge shortfall in the survey and inspection of sick and manufacturing units. Inordinate delay was observed in the testing of drugs and consequential action against the manufacturers/sellers of sub-standard drugs. There was lack of adequate infrastructure facilities for quality testing of samples collected. Price control mechanism was not in vogue. The possibility of manufacture and sale of sub-standard drugs and cosmetics could not be ruled out and the intended objective of making available essential life saving drugs at fair prices to masses was not realised. Main audit findings are summarised below: 1. The Controller of Drugs did not have a master control register which would indicate the actual status of manufacturing/selling units of the State and licenses to manufacturing/selling units were not periodically renewed, though required. 2. Targets for inspection of selling/manufacturing units in the State fell short by 59 to 68 per cent during 1998-2003. In 25 districts, inspections carried out by 34 Drug Inspectors fell short by 79 to 86 per cent. 3. Samples collected fell short of targets by 96 to 97 per cent. Only 75 per cent of samples of drugs collected during 1998-2003 by the State Drug Control Laboratory, Patna were tested. Government Analyst attributed the shortfall to inadequate infrastructure such as chemical, power supply, testing equipment and manpower. 4. The Controller of Drugs did not initiate punitive and deterrent action in respect of 122 cases of sub-standard drugs reported by five Regional Licensing Authorities during 1998-2003. 5. Interface of State Drug Regulatory Authority with pharmaceutical industry/trade, consumers and medical professionals was non-existent. This adversely affected dissemination of information and feed back on the functioning of enforcement authorities. 6. No intelligence branch was set up for keeping a watch on illegal manufacture of drugs and its trade activities. No training was imparted to Drug Inspectors to tone up enforcement of the Act. 7. Controller of Drugs stated that there was no price control mechanism in vogue in the State. 8. There was lack of monitoring and evaluation mechanism to ensure effective implementation of the provisions of the Drugs and Cosmetics Act, 1940.
Performance Audit of Drugs and Cosmetics Act in Haryana
(CAG of India, 2004) CAG of India
Medical and Health Department in Haryana was responsible for enforcing the provisions of the Drugs and Cosmetics Act and Rules framed thereunder. These legislations were enacted with the objectives to ensure availability of standard and safe drugs and cosmetics, availability of drugs at fair and affordable prices to the consumers and to see that the drugs were promoted through projection of factual information only. This performance audit pointed out that the department, however, did not have adequate infrastructural resources and manpower to effectively discharge the regulatory functions. There was shortfall in inspections of drug units to check compliance of provisions of the Act. In large number of cases, the firms continued their business without getting their licences renewed. Collection of drug samples for quality control was arbitrary as no sample was collected from large number of units for several years. Sub-standard and spurious drugs were in sale in market and were supplied even to the Government hospitals. The department thus, failed to achieve the objectives enshrined in the Act. Important points noticed in audit were as under: • Against the requirement of 50 Drug Inspectors, as per norms recommended by the task force of the Central Council of Health and Family Welfare, only 16 were in position. This led to a situation where against the requirement of 52,913 inspections covering 6,100 to 8,051 Allopathic/Homeopathic drug selling units in the State during 1998-2003, 21,473 inspections were carried out by Drug Inspectors, resulting in shortfall of 59 per cent. For inspection of 230 to 366 Ayurvedic/ Unani drug manufacturing units in the State, shortfall was 37 per cent during 1998-2003. • Testing facilities were not available with the State Drug Laboratory for any of the Homeopathic, Ayurvedic and Unani medicines nor any alternative arrangements for their testing were made. Also, for large number of allopathic drugs, these facilities were not available. • Seventy four per cent of the drug samples were tested after prescribed period of 45 days from the date of collection of samples. The delay ranged between one and half month and one and half year. Licences of 25 out of 38 Blood Banks in the State were not renewed for the last two to seven years although they continue to be in operation. • Prosecution cases increased from 324 in 1997-98 to 522 in 2002-03. The department did not take up the case for setting up special designated courts with the Government for their speedy disposal. • Records of complaint cases were not maintained properly. Details made available disclosed that 227 cases were pending as of March 2003. Appropriate speedy action was not taken against the defaulters.
Performance Audit of Drugs and Cosmetics Act in Karnataka
(CAG of India, 2004) CAG of India
Performance Audit of Implementation of Drugs and Cosmetics Act in Karnataka covering the period 1997-98 to 2002-03 revealed huge deficiencies in inspection, drawal and analysis of sample drugs and laxity in monitoring compliance with the results of analysis. This indicated that Department of Drugs Control had not discharged enforcement functions effectively. Improper decisions favouring licensees, reporting results of analysis after expiry of validity date of drugs and abnormal delay in a few other cases facilitated marketing of drugs found ‘not of standard’ quality. Drugs Controller had no information regarding number of seizures of sub-standard/ fake drugs. In test-checked Circle Offices, such drugs were seized only in 48 cases (seven per cent) out of 671 ‘not of standard’ drugs. Abnormally low percentage of seizures indicated lack of determination to prevent marketing of drugs found ‘not of standard’ quality. Drug testing laboratory was found deficient in equipment, manpower and methods of analysis, as a result of which 2,032 samples could not be analysed and were given ‘no opinion’ report. Performance of intelligence wing was unsatisfactory considering that action in respect of 826 cases (86 per cent) out of 961 complaints was pending for periods ranging from one to seven years.
Performance Audit of Drugs and Cosmetics Act in Maharashtra
(CAG of India, 2004) CAG of India
The Drugs and Cosmetics Act, 1940 is an important social legislation and is a very effective tool for safeguarding the consumers’ interest. Provisions of Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules 1945 regulate the import, manufacture, distribution and sale of drugs and cosmetics in the country. Adulteration of drugs and production of spurious and substandard drugs causing serious threat to the health of the community are also sought to be prevented by application of the provisions of the Act. However, this performance audit of implementation of Drugs and Cosmetics Act in Maharashtra revealed that the Act has not been implemented effectively. The provisions of the Act regarding licensing and inspection of units, drawing/testing/reporting of samples, timely and effective actions against those manufacturing and selling substandard/spurious drugs were not implemented meticulously.
Performance Audit of Drugs and Cosmetics Act in Punjab
(CAG of India, 2004) CAG of India
The Drugs and Cosmetics Act, 1940 (Act) is a Central Act and is applicable to the whole of India. This Act alongwith the other associated Acts and the rules made thereunder regulate the manufacture, sale, import, export and clinical research of drugs and cosmetics in India. While the parameters of control are devised by the Central Government, these are required to be actually implemented by the State Government. Dereliction occurs in the implementation of regulatory parameters especially in the areas of licensing, approval, monitoring, prosecution, inspection and recall of substandard/spurious drugs. This performance audit of implementation of Drugs and Cosmetics Act, 1940 in Punjab, for the period 1998-99 to 2002-03 revealed that the Act has not been implemented effectively in the state. The provisions of the Act regarding inspection of units, drawing/testing/reporting of samples, speedy and effective action against those manufacturing and marketing sub-standard/spurious drugs were not implemented strictly and meticulously. There was shortfall in conducting inspections of manufacturing units and action against drug offenders was inadequate. There was no co-ordination with other States/State Vigilance Authorities for tracking down the activities of drug offenders.
Performance Audit of Drugs and Cosmetics Act in Odisha
(CAG of India, 2004) CAG of India
A review of the implementation of the Drugs and Cosmetics Act, 1940 in Odisha during the period 1998-2003 revealed vital lapses in enforcement of major provisions of the Act by the State Drug Control Authorities (SDCAs). There were shortfalls in inspection of premises of the units licensed for manufacture and sale of drugs. Medicine shops, blood bank and manufacturing units of Large Volume Parenterals (LVP) were allowed to continue without valid licence. While the State Drug Testing and Research Laboratory lacked infrastructure to test all types of allopathic drugs, there was absence of a State level laboratory for testing of ayurvedic and homoeopathic drugs. Besides, the State machinery was not effective in recalling from the market drugs declared not of standard quality, to check their further use.
Performance Audit of Drugs and Cosmetics Act in Rajasthan
(CAG of India, 2004) CAG of India
The Drugs and Cosmetics Act, 1940 (the Act) is a Central Act and is applicable to the whole of India. This Act and the rules made thereunder regulate the manufacture, sale, import, export and clinical research of drugs and cosmetics in India. While the parameters of control are devised by the Central Government, these are required to be actually implemented by the State Government. This performance audit of the implementation of Drugs and Cosmetics Act, 1940 in Rajasthan carried out by the CAG of India covering the period 1998-99 to 2002-03 revealed that in Rajasthan, the Act has not been implemented effectively. The provisions of the Act regarding inspection of units, drawing/testing/reporting of sample, speedy and effective action against defaulters were not implemented strictly. There was shortfall in conducting inspections of units and action against drug offenders was inadequate. There was no proper coordination among the Drug Control Organisations of various States. There was serious risk, therefore, of fake/spurious/not of standard quality drugs being supplied to consumers in the State. There was delay in sending of samples to laboratories for analysis, delayed reports of analysis even after expiry of drugs, full consumption of stock of “not of standard quality” drugs, and shortfall in sampling of all categories of drugs.
Performance Audit of Drugs and Cosmetics Act in Uttar Pradesh
(CAG of India, 2004) CAG of India
The Drugs and Cosmetics Act, 1940 was enacted to combat production and marketing of spurious / not of standard quality(NSQ) drugs and cosmetics causing serious health hazards and even death of consumers. This performance audit of implementation of Drugs and Cosmetics Act, 1940 in Uttar Pradesh carried out by the CAG of India covering the period 1998-99 to 2002-03 revealed that due to various inadequacies in implementation of the provisions of the Act in the State such as acute shortage of Drug Inspectors, faulty system of licensing, shortfalls in inspections of manufacturing/selling units and collection of samples, inefficient Government Laboratories and non-appointment of the Government Analyst for Homeopathic medicines etc. the consumers were prone to risk of health hazards. Monitoring and evaluation of the implementation of the provisions of the Act was, by and large, non-existent.
Performance Audit of Drugs and Cosmetics Act in West Bengal (1998-2003)
(CAG of India, 2004) CAG of India
The Drugs and Cosmetics Act, 1940 was enacted to combat production and marketing of spurious / not of standard quality drugs and cosmetics causing serious health hazards and even death of consumers. This performance audit of the implementation of Drugs and Cosmetics Act, 1940 in West Bengal carried out by the CAG of India covering the period 1998-99 to 2002-03 revealed that due to various inadequacies in implementation of the provisions of the Act in the State, the consumers were prone to serious health hazards.
Performance Audit of Drugs and Cosmetics Act in Andhra Pradesh
(CAG of India, 2004) CAG of India
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. This performance audit by the CAG of India covering the period 1998-99 to 2002-03, revealed that in Andhra Pradesh the Drugs Control Administration (DCA) was functioning with only 55 Drugs Inspectors (DIs) for the last 10 years against the requirement of 240. Huge shortage of DIs adversely affected the functioning of the DCA and menace of spurious drugs continued to prevail. No follow-up action was taken to withdraw the drugs (from the market) declared as not of standard quality. 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.

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