Over 200 drug packaging units face closure after ban on PET use

Plastics industry protests the move, says no scientific data supports govt's claim, alternative use of packaging material would be costlier

Over 200 small and medium size polyethylene terephthalate (PET) converters specially those dedicated to packaging of drug formulations have started shutting down operations due to ban of PET for pharma packaging.

Of the 600,000 tonnes of PET production, pharmaceutical industry uses around 16% constituting around 100,000 tonnes every year. Additionally, Coke and Pepsi use PET bottles for packing soft drinks abundantly.

Hence, of the Rs 4,000 crore industry size, between Rs 1,000-1,500 crore worth of business be directly hit due to the government's decision to prohibit use of PET in liquid oral formulations for primary packaging of drug formulations.

The Ministry of Health and Family Welfare through a notification dated September 29, said, "No manufacturer shall use the PET or plastic containers in liquid oral formulations for primary packaging of drug formulations for paediatric use, geriatric use and for use in case of pregnant women and women of reproductive age group."

The notification warns that in case of violation of the said provision shall be liable to penalty under the provisions of the Drugs and Cosmetics Act, 1940. The ban, however, will be made effective by March 2015.

"The government's ban is based on wrong facts submitted to the concerned Ministry. Despite no scientific study across the world proves PET's harmful affect, the government prohibited its use in primary packaging of formulations. Over 200 manufacturing units with an estimated annual business worth Rs 1,000-15,000 crore will be shut down. In fact, they have already started collecting outstanding in the market," said Udit Seth, Managing Director of Pearl Polymers, the manufacturer of Pearlpet brand PET bottles.

Meanwhile, plastic manufacturers have strongly objected to the proposed ban. In a letter to the Ministry, 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 (Global Regulatory Affairs) of the Society of the Plastics Industry, Inc, 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 have also joined the move. In a letter to the Health Ministry, the All India Plastics Manufacturers Association (AIPMA) said that the use of PET bottles has been statutorily permitted and regulated after thorough evaluation and testing. The Food and Drug Administration (FDA) of USA has certified after diligent research and found no harmful impact for 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.