Rs 15,000 Cr Worth Fake And Counterfeit Drugs In Market: Association

The fake and counterfeit drugs are widely disbursed to the extent of Rs 15,000 crore per annum, registering 20-25 per cent growth every year, according to a survey carried out by Associated Chambers of Commerce and Industry of India (Assocham).

Sale of fake and spurious drugs in the NCR region itself amounted to Rs 300 crore annually and it constituted up to 25 per cent of the total medicines sold in the region, extending severe impacts on the original drug manufacturers and treatment. Areas like Ghaziabad, Meerut, Noida, Faridabad, Gurgaon and Sonepat were the hubs for spurious drugs, the data in the survey said.

Lamenting on the lack of designated agencies to keep strict watch and take punitive action to penalize fake drugs manufacturers in the region, the chamber has suggested creation of NCR Drugs Protection Authority to monitor nefarious activities of fake and counterfeit drugs manufacturers and to begin the action.

Assocham secretary general D S Rawat pointed out that other pockets within the NCR in which counterfeit drugs sale is affected without any fear include Mohan Nagar, Dadri, Surajpur, Suburb of Faridabad, Gurgaon and Haryana. The key factors for the spread of fake drugs in NCR comprise the shortage of drug inspector and proper lab facilities to check purity of drugs, storages of spurious drugs by the chemists, weakness in drug distribution system, plenty of uneducated workforce in NCR and lack of enforcement. These all reasons have given the liberty to fake drugs manufacturers and druggists to supply the spurious drugs in the region.

"Majority of such drugs is devoid of necessary ingredients estimates for which exceed even 40 percent and therefore the government concern should activate drug inspectors to catch the guilties. The fake drugs makers not only damage the society but evade taxation such as excise, VAT and local levies and subject the concern governments to revenue losses which run into thousands of rupees," the survey said.

The concentration of fake drugs, manufacturers can largely be found out in locations such as Bahadurgarh, Ghaziabad, Aligarh, Bhiwadi, Ballabhgarh, Sonepat, Hisar and Punjab. These factories are located close to the bordering areas to access bulk supplies in the NCR region without any fear of being caught. NCR has limited drugs inspectors to monitor over 3300 chemists and over 30 percent chemists are based in small areas of NCR. "In view of limited routine checking by drugs inspectors, these chemists are storing large stock of spurious and fake drugs and most of them are purchased by unskilled and rural areas patients. NCR has also very few laboratories in the region with proper infrastructure to check the correct ingredients in drugs," it said.

"For traders manufacturing fake drugs, the profits margins are very high with no apparent risk. The fake drugs are available in the popular medicines like Crocin, Voveran, Betadine, injections of calcium and syrups like Cosavil. The fake drugs business are also turned into a massive racket and even the government run hospitals in NCR have been witnessed the availability of fake drugs to the extent of 10-15 percent. It should also carry out a survey of drugs for their genuineness and quality. For this purpose, large sample survey need to be carried out in different parts, separately for Metros, small cities, towns and rural areas" said Rawat.

(Ref: The Chronicle Pharmabiz dated 14, February 2008)

Indian Drug Manufacturers' Association (IDMA) has suggested to the central government that the centre should strengthen the existing Central Drugs Standard Control Organization (CDSCO) as recommended by Dr Mashelkar Committee and as declared in Pharmaceutical Policy 2002, instead of forming Central Drug Authority (CDA).

In a memorandum submitted recently to the joint director, Rajya Sabha Secretariat, the IDMA suggested that the centre should create strong, well equipped, independent and professionally managed CDSCO and to create separate division under CDSCO as per recommendations of Dr Mashelkar Committee. It has also suggested not to create a Central Drugs Authority by substituting a drugs Technical Advisory Board constituted under Section 5 of the Drugs and Cosmetic Act, 1940 and Ayurveda, Shidha and Unani Drugs Technical Advisory Board constituted under Section 33 C of the Act.

According to the IDMA, both these statutory bodies are broad based and are technical in nature. On the other hand, the proposed CDA will have only five members to be appointed by the central Government. The provision of section 5 of the proposed bill indicates that the central government is not bound to appoint technical experts on the Central Drugs Authority. It also said that the Drugs and Cosmetics Act, 1940 and its implementation is highly technical in nature and requires the advisory bodies comprising technically qualified experts.

It may be noted that the Drugs and Cosmetics (Amendment) Bill 2007 was presented in Rajya Sabha on August 21, 2007 and was later referred to the Parliamentary standing committee to examine and put forth its suggestions. The committee invited suggestions from pharma associations and other stake holders on formation of CDA and these associations and other stake holders sent their suggestions to the committee