Expressing concern over the rising menace of counterfeit medicines in the country, Sudhansh Pant, joint secretary, Department of Pharmaceuticals (DoP), has called upon the pharmaceutical companies to comply with the Directorate General of Foreign Trade (DGFT) notification on bar coding on packages to facilitate tracking and tracing of their products.
Addressing a gathering of pharma industry honchos at 'PharmaSafe India', a two-day conference on anti-counterfeiting and brand protection held on November 24-25, 2015 in Mumbai, Pant said, “The pharma units in the country have been slow to adopt bar coding on packages to tackle counterfeiting menace. The country has around 10,000 pharma units and out of that around 8,000 are small and medium size units. They are yet to adopt anti-counterfeit technologies. The small and medium size units want government to allocate funds for the same, but it is not feasible for the government to allocate funds to the units to adopt anti-counterfeit technologies.”
He said that bar coding on primary packaging -- ampoules, vials, bottles, cartridges and blisters that contain medicines-- has been postponed due to technical issues raised by the industry.
He called upon the industry which is reluctant to adopt the anti-counterfeit measures citing extra cost and bad publicity to make investment in the anti counterfeit technologies in their future growth.
He assured the industry leaders that the government wants compliance of DGFT notification related to bar coding on packaging with involvement of industry.
He said that the prevalence of fake medicines is high in remote areas. Branded products are likely to fall prey to counterfeiting. If companies come across any incident of counterfeiting, they should file complaint with state drug regulators.
Dr. K Bangarurajan, Deputy Drugs Controller of India, west zone, said “In 2008, Drugs and Cosmetics Act was amended to provide compensation to family of the person who lost his life due to use of spurious drug. Adulterated under section 17E is punishable with imprisonment for a term which may extend to three years and with fine which is not less than Rs 50,000 or three times the value of the products confiscated. As per the amendment to D&C Act in 2008, whistle blower is entitled to get 20 per cent of value of drugs seized.”
He said that the government has plans to increase the number of CDSCO labs and state government labs to strengthen mechanisms to rein in the counterfeit medicine.
Omprakash Sadhwani, joint commissioner of food and drug administration, Maharashtra emphasised on strong coordination between all stakeholders including pharma industry, drug wholesalers, retailers to tackle counterfeit medicine problem.
Dr. Shailesh Ayyangar, president of Organisation of Pharmaceutical Producers of India (OPPI) said “We are setting up anti-counterfeiting cell and have plans to tie-up with other pharma bodies such as IDMA, IPA, AIOCD and government bodies.”
Multinationals pharma industries have stepped up campaign against spurious drugs. They have taken steps to curb sale of fake medicines through laboratory tests, enhanced packaging and awareness drives.
Sanofi is gathering and testing product samples from across the world including India at its specialised laboratory in France.
"We have chalked out plans to prevent sale of spurious medicines and have come up with a detection plan," said Dominique Woloch, Sanofi's regional security director. “We have a team of 80 officers engaged in anti counterfeiting.”
Woloch and his team has confiscated millions of spurious products in raids across the world. Besides laboratory tests, Sanofi has taken up product protection and authentication plans, training of medical representatives and awareness drive against spurious medicines.
Ajit Singh, chairperson of ACG Worldwide, a pharma manufacturing and packaging solutions provider, said “Pharma industries were earlier reluctant to adopt anti-counterfeit technologies due to a host of issues including extra cost and bad reputation, but now trend is changing. They are making investment in anti counterfeiting technologies to reduce financial loss.”