A number of small and medium size polyethylene terephthalate (PET) converters specially dedicated to packaging of drug formulations have begun shutting down operations, says the industry, as a sequel to the central government order banning the material's use in this regard.
Of the 600,000 tonnes of PET production, the pharmaceutical industry uses 16 per cent or around 100,000 tonnes every year. Coca-Cola and PepsiCo also use PET bottles for their soft drinks.
Of the Rs 4,000-crore industry size, Rs 1,000-1,500 crore of business is estimated to have been hit by the government's decision to prohibit use of PET in packing of liquid oral formulations. The order was issued in the September-end, to take effect by March.
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"The government's ban is based on wrong facts. No scientific study proves PET's harmful effect, the government prohibited its use in primary packaging of formulations. At least 200 manufacturing units will be shut down; they have already started collecting their dues," said Udit Seth, managing director of Pearl Polymers, maker of the Pearlpet brand of these bottles.
In a letter to the ministry, the Washington-based The Plastic Industry Trade Association, said: "Drug manufacturers will be forced to exit the Indian market if they are unable to identify suitable packaging options. This will result in shortages of drugs that would be available to some of India's most vulnerable populations. Those companies that remain in the market will likely be compelled to charge higher prices for drug products to absorb the costs associated with alternate packaging, making it more difficult for India's people to afford needed drugs."
Kyra M Mumbauer, senior director at the Washington-based Society of the Plastics Industry, said: "The North American plastics industry firmly believes that this rule, prohibiting the use of PET and other plastics for primary packaging of liquid oral drug formulations for paediatric and geriatric populations, as well as pregnant women and women of child-bearing age, is based on faulty and incorrect scientific data and assumptions. Several Indian drugs packed in plastics/PET are also exported worldwide. This again proves the suitability of plastics/PET for packing various pharmaceutical products, including liquid formulations."
Indian plastic manufacturers are protesting, too. The All India Plastics Manufacturers Association has written to the ministry that the use of PET bottles was permitted and regulated after thorough evaluation and testing. The US Food and Drug Administration, it contends, has certified after diligent research that no harmful impact was evident on use of PET bottles for storage of food, pharmaceutical and alcoholic products.
"Therefore, the government should immediately withdraw the notification immediately," said Rituraj Gupta, President, AIPMA.