| European Union has opted for the acceptance of | | | | products, hence are not exempted under REACH |
| REACH regulations on 1st June, 2007. REACH stands | | | | regulations. Intermediates for APIs need to be |
| for Registration, Evaluation, Authorization and | | | | pre-registered before the deadline of 30th Nov, 2008 |
| Restriction of Chemical. The regulation is adopted for | | | | and then processed for its registration procedure. |
| streamlining and improving the former legislative | | | | Intermediates for the APIs can be classified again |
| framework on chemicals of the European Union. The | | | | under 2 main categories under REACH: |
| regulations has put the Burden of Proof" on the | | | | * Non-isolated intermediates |
| industry to manage the risks that chemicals may | | | | * Isolated intermediates |
| pose to the health and the environment. REACH | | | | * On-site (non transported) isolated intermediates |
| regulations covers not only industrial chemicals but | | | | * Transported isolated intermediates |
| also chemicals, which are used in our day-to-day life | | | | A non-isolated intermediate is an intermediate that |
| (e.g. paints, dyes used for clothing, etc.) | | | | during synthesis is not intentionally removed (except |
| Objectives of implementing REACH regulations are: | | | | for sampling) from the equipment in which the |
| * Improve the protection of human health and the | | | | synthesis takes place. |
| environment from the risks that can be posed by | | | | On-site isolated intermediate means an intermediate |
| chemicals | | | | not meeting the criteria of a non-isolated intermediate |
| * Enhance the competitiveness of the EU chemicals | | | | and where the manufacture of the intermediate and |
| industry, a key sector for the economy of the EU | | | | the synthesis of another substance from that |
| * Promote alternative methods for the assessment | | | | intermediate take place on the same site, operated |
| of hazards of substances | | | | by one or more legal entities. |
| * Ensure the free circulation of substances on the | | | | A transported isolated intermediate is an intermediate |
| internal market of the European Union. | | | | not meeting the criteria of a non-isolated intermediate |
| All the exporters and importers of chemicals will | | | | and transported between or supplied to other sites. |
| identify and manage the risks and hazards associated | | | | Under REACH regulations, non-isolated intermediates |
| with the chemicals that they manufacture and | | | | are exempted from review process as non-isolated |
| market. REACH requires manufacturers and importers | | | | intermediates remain in the reaction process and are |
| of chemicals to produce data on all chemical | | | | not isolated. |
| substances that are produced or imported into the | | | | Most of Indian pharmaceutical companies exporting |
| EU in volumes above one ton a year. Appropriate risk | | | | intermediates for APIs would fall under the perview |
| management measures must also be identified and | | | | of the "Isolated intermediates" category for which |
| users informed of them. | | | | the companies will need to undergo review procedure |
| REACH regulations are imposed on manufacturers or | | | | under REACH regulations. |
| importers of chemicals of more than 1 metric ton per | | | | Relief under Strictly controlled conditions: |
| annum per company. For companies who are | | | | For both on-site and transported isolated |
| manufacturing and exporting more than 1 metric ton | | | | intermediates, there is possibility to provide a reduced |
| of a chemical to Europe will need to register the | | | | set of information for their registration under the |
| chemical by submitting the dossier and proving that | | | | following conditions: |
| the chemical is safe to use. Potential registrants (i.e. | | | | * For on-site isolated intermediates, the manufacturer |
| manufacturers and importers of chemicals) must | | | | confirms that the substance is only manufactured |
| 'pre-register' these substances by December 1, 2008. | | | | and used under strictly controlled conditions in that it |
| Those that are not pre-registered by that date will | | | | is rigorously contained by technical means during its |
| have to undergo a full registration process in | | | | whole life cycle. |
| December, or be withdrawn from sale. Supply of | | | | * For transported isolated intermediates, the |
| substances to the European market, which have not | | | | manufacturer or importer confirms himself or states |
| been registered, would be considered as illegal. | | | | that he has received confirmation from the user that |
| REACH regulations are managed by European | | | | the synthesis of another substance from that |
| Chemicals Agency (ECHA), which will operate from | | | | intermediate takes place on other sites under strictly |
| Helsinki, Finland. | | | | controlled conditions. |
| Although, REACH regulations cover all chemicals, | | | | Adding to the above-mentioned brief overview of |
| exemptions are provided for medicinal products. | | | | REACH regulations, all the steps of registration under |
| Hence, all active pharmaceutical ingredients (APIs) and | | | | REACH regulations are expensive as all the products |
| their finished dosage forms are exempted from the | | | | (other than exempted products) need to be |
| cover of REACH regulations. | | | | registered individually. |
| There are many companies in India, which | | | | In conclusion, impact of REACH regulations in India's |
| manufacture and exports intermediates for APIs to | | | | Pharmaceutical sector would |
| clients in European countries. Indian companies | | | | * potentially disrupt the supply of intermediates for |
| consider intermediates for APIs as a huge market. As | | | | APIs |
| intermediates for APIs are not classified as medicinal | | | | * push up drug prices. |